A Randomized Controlled Clinical Trial on Multimodal Prehabilitation in Colorectal Cancer Patients to Improve Functional Capacity and Lower Postoperative Complications.
Phase: NA
Conditions: Colon Cancer, Prehabilitation
Sponsor: University Hospital of Ferrara

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Tissue, organ and systemic injury responses to surgery, trauma, burn, sepsis, hemorrhage, ischemia-
reperfusion, or resuscitation, including integrating pathways and signals.
Surgery, Anesthesiology, and Trauma - SAT
Project Classification SS:
Surgical Sciences, Biomedical Imaging, and Bioengineering
Prehabilitation
Project Keyword 2:
Project Keyword 3:
Project Keyword 1:
Physical function and postoperaive complications
Project Classification IRG:
Project duration (months):
36
Project Request:
Animals:
Humans:
X
Clinical trial:
X
The object/s of this application is/are under patent copyright Y/N:
Oncologia
Major Diagnostic Category*:
Operative Units / WP
INSTITUTION
Department/Division/Lavoratory
Role in the project
1
Emilia-Romagna
Department of Surgery/U.O. Chirurgia Generale
Provinciale - Azienda USL di Ferrara
Conception of the study and research hypothesis, enroll and
operate on patients, evaluate and treat mood and
psychological disorders of the patients, coordination of the
study
2
Azienda Usl di Ferrara - Emilia-
Romagna
Department of Sports Medicine/Division of
Excercise and Sports Medicine - Azienda USL di
Ferrara
Prehabilitation of surgical patients
3
Azienda Ospedaliero-Universitaria di
Ferrara -
Emilia-Romagna
Department of Medicine/Division of Internal
Medicine/Center for Clinical Epidemiology -
Azienda Ospedaliero- Universitaria di Ferrara
Design and implemementation of the study and statistical
analysis
Investigators, Institution and Role in the Project
Co-PI
Under40
Key Personnel
Institution/Org./Pos.
Role in the project
Birth Date
1
X
Grazzi Giovanni
Azienda Usl di Ferrara - Emilia-Romagna Prehabilitation and rehabilitation of surgical
patients
08/11/1957
2
VOLPATO STEFANO
Azienda Ospedaliero-Universitaria di
Ferrara -
Emilia-Romagna
Design and implemementation of the study
and statistical analysis
05/11/1966
3
X
DE TROIA ALESSANDRO
Azienda Ospedaliero-Universitaria di
Ferrara -
Emilia-Romagna
Screening and enrollment of elegibile
patients
03/11/1983
4
CARUSO ROSANGELA
Emilia-Romagna
Evaluate and treat mood and psychological
disorders of the patients
18/02/1974
Overall Summary
Postoperative complications occur in up to 50% of patients and are associated with higher mortality, cancer recurrence rate
1  /  33
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Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
and hospital costs. The number and severity of complications are closely related to preoperative functional capacity and
nutritional status. This study aims to determine the effect of prehabilitation on patients' functional capacity and postoperative
complications. It is a randomized trial including 112 patients undergoing colorectal surgery for cancer. Patients will be
allocated to intervention group receiving 4 weeks trimodal prehabilitation (N=56) or control group receiving no prehabilitation
(N=56). After surgery, both groups will follow 8 weeks rehabilitation based on Enhanced Recovery After Surgery (ERAS)
guidelines. The primary endpoint is functional capacity, secondary outcomes include postoperative complications and a
cost-effectiveness analysis. Multimodal prehabilitation is expected to increase functional capacity and lower postoperative
complications.
Background / State of Art
Postoperative complications occur in up to 50% of patients undergoing cancer colorectal resection and are associated with
poor prognosis, increased costs, and lower health-related quality of life (HRQoL).1-3 Even with no complications, major
surgery is associated with 20 to 40% reduction in physiological and functional capacity and higher level of fatigue 6 to 8
weeks after surgery.4 Functional performance reduction is correlated with preoperative health status and degree of surgical
trauma as well as intensity of metabolic response. Patients may also need postoperative chemo- and radiation therapy,
more physically challenging if surgery has lowered functional capacity. Many negative effects of major surgery can be
reduced attenuating the surgical stress response by Enhanced Recovery After Surgery (ERAS) programs, to facilitate
return of functional activities and accelerate convalescence.5 However, the postoperative period may not be the best time
to ask surgical patients to change their nutrition and exercise habits, as they may be tired, anxious, and depressed awaiting
for additional treatments. Also, poor baseline physical performance capacity, particularly in the elderly and frail patients,
increases the risk of complications and prolongs recovery after major surgery. Thus, patients' prehabilitation, the process of
enhancing functional capacity to withstand an incoming stressor between the time of cancer diagnosis and surgical
treatment, may represent a better time frame to intervene in factors contributing to the recovery process enhancing
recuperation of postoperative functional capacity.6,7 A recent systematic review including 20 studies evaluating the
prehabilitation program in gastrointestinal cancer surgery, strongly supported multimodal rather than unimodal
interventions, but highlighted the need for further prospective studies, also evaluating health economic outcomes, before
the definitive value of prehabilitation programs can be clarified.8
Si
It’s available a Systematic Review on this topic?
Si
It’s available as publication please report bibliographic data?
10.1097/DCR.0000000000000987
Bibliographic data (DOI):
Hyphotesis and Specific AIMS
Hyphotesis and Significance:
Recent level I evidence from North America suggests that optimizing functional exercise capacity alone before colorectal
surgery can result in better physical performance, but not significant fewer postoperative complications and shorter hospital
length of stay (LOS).9,10
In this study, we hypothesise that the implementation of a trimodal prehabilitation program (physical exercise, psychological
support and nutritional optimization) in patients undergoing ERAS colorectal resection for cancer with standard
rehabilitation will determine: 1) better physical performance at 8 weeks after surgery, 2) decrease in postoperative
2  /  33
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Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
complications and LOS, and 3) reduced direct and indirect costs.
To date, there is no evidence of the implementation of such a trimodal prehabilitation program in Italy and the only
published RCT was conducted in Canada, a very different social, economic and environmental context. Furthermore, in this
study the mean age of patients who underwent prehabilitation was 65.7 years and 74% were ASA I-II.
Preliminary Data:
Since 2013, at the University Hospital of Ferrara a multidisciplinary team including surgeons, anaesthesiologists, and
nurses has implemented an integrated ERAS perioperative care protocol in colorectal surgery, founded on elements
selected based on high-grade evidence of clinical efficacy.5 Recently, also two dietitians, a geriatrician with
consolidated experience in sarcopenia and performance-based functional assessment of older patients, two sports
medicine physicians, and two psycho-oncologists have joined the team to integrate the ERAS methodology with a
prehabilitation colorectal program.
Recently, the prehabilitation protocol has been applied by the team to a small number (N=10) of patients who underwent
ERAS colonic resection for cancer. According to the protocol, patients were evaluated at baseline and after a 4-week
prehabilitation program with the 6-minute walking test (6MWT). Mean baseline walking capacity was 571.5 ± 64.1 m, while
following the 4-week prehabilitation program increased to 618.8 ± 57.5 m. At present, we are still collecting the
postoperative data on walking capacity.
Picture to support preliminary data:
Boxplot preliminary data.jpg
Specific Aim 2:
Specific Aim 1:
Specific Aim 3:
To compare the postoperative functional capacity in two groups of colorectal cancer patients undergoing colorectal
resection following an ERAS program, one treated with trimodal prehabilitation before surgery followed by standard
rehabilitation (experimental group) and the other undergoing standard rehabilitation alone after surgery (control group).
To compare the postoperative complications in the experimental group versus the control group.
To compare both direct (hospital) and indirect (social and non-hospital health care) costs in the experimental group versus
the control group.
Experimental Design Aim 1:
Single centre, single-blind, RCT with 2 groups. Written informed consent will be obtained. Ethical approval was obtained by
the local Ethics Committee.
Patients of age >17 years undergoing elective colorectal resection for cancer are eligible. Exclusion criteria are metastatic
disease, severe walking impairments, renal failure stage >2, ASA score >3, preoperative chemo-radiation therapy.
Patients will be randomized either to prehabilitation intervention group, receiving 4-week prehabilitation, or to control
receiving no prehabilitation. Both groups will receive rehabilitation following current international ERAS guidelines.
The primary outcome for functional capacity is measured by the 6MWT, chosen because it is a validated, objective
measure of colorectal surgery recovery integrating all components of physical activity.10
Secondary outcomes for aim 1 are: a) cardiopulmonary exercise testing (CPET), b) handgrip strength, c) sit-to-stand, d)
3  /  33
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Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Experimental Design Aim 2:
Experimental Design Aim 3:
body composition and nutritional status, e) depression/anxiety, f) HRQoL.
All measures will be recorded in both study groups at baseline (beginning of prehabilitation period) and prior to surgery (end
of prehabilitation period) to measure the effect of intervention, and at 4 and 8 weeks after surgery to assess the impact of
the intervention throughout the perioperative period. The person performing the 6MWT and helping the subjects with
questionnaires and forms will not be aware of the study hypothesis and will not have access to data.
ELEMENTS OF TRIMODAL PREHABILITATION:
1) EXERCISE PROGRAM. A sports physician will assess patients mobility and capacity to exercise. All participants will
undergo CPET and the exercise intensity will be defined and personalized. Based on the evaluation, the sports physician
will prepare, explain and coordinate a personalized program.11
Patients will receive 3 supervised trainings/week including interval and resistance training. They will be instructed on how to
conduct aerobic exercises at home (walking or cycling), initially at 50% of the calculated heart rate reserve aiming at 60 min
4 times/week as tolerated by the patient. Accurate measurement of compliance is critical to determine the true effect of
prehabilitation; therefore, patients will always wear an accelerometer during the 4 weeks of intervention.
2) NUTRITIONAL SUPPLEMENTS. The goal is to attain an anabolic preoperative state in all patients, improving in
cachectic patients the lean body mass amount. At baseline, dietician will assess patients nutritional status (body
composition, caloric balance and dietary intake). Nutritional supplements will be tailored to patient food intake. If there is
weight loss/cachexia and indication for extra feeding and no medical limitation increased protein intake is aimed at 1.5
g/kg/day. Extra supplements as multivitamins and 2 weeks of omega-3 fatty acids from fish oil will be added.
3) PSYCHOLOGICAL COPING. Patients undergoing surgery for cancer may be anxious with depression symptoms which
may influence social and functional activities. Thus, patients will be evaluated by a trained psycho-oncologist using
validated questionnaires (GAD-7, PHQ-9).12,13 The goal is to reduce anxiety and avoid depression by putting the patients
in a well-informed active coping role in dealing with the disease. If indicated, patients will receive 90 min of psychological
intervention in the first session and more sessions during the 4 weeks of prehabilitation. In the first preoperative session,
the 1st hour will address the patients anxieties, coping strategies, and post-operative expectations. The last 30 min will be
devoted to teaching relaxation techniques and breathing exercises and to give written instructions for home practice.
CONTROL GROUP
Patients will be encouraged to walk daily for at least 30 min, to perform breathing exercises for 5 min per day and 5-10 min
of aerobic exercises.
The Clavien-Dindo classification and the Comprehensive Complication Index (CCI) as a combined outcome measure of
morbidity and mortality will be used to assess complications.14,15 CCI is calculated as the sum of all complications that are
weighted for their severity (multiplication of the median reference values from patients and physicians). The final formula
yields a continuous scale to rank the severity of any combination of complications from 0-100 in a single patient. The CCI
showed high sensitivity detecting treatment effect differences, inverse correlation with postoperative health status, and high
correlation with the results of patient-rated single and multiple complications on conjoint analysis (r=0.94, P<0.001). The
CCI summarizes all postoperative complications and is more sensitive than existing morbidity endpoints.15 Both indexes
will be assessed 4 weeks after surgery.
The analysis of social costs for patients in the prehabilitation and control groups will be assessed by cost-effectiveness
analysis, evaluating both direct and indirect costs, including the value of time spent by unpaid caregivers (formal and
informal) in assisting the patients. Costs and benefits will be evaluated from the societal point of view. Costs (both public
4  /  33
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Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
and private as well as direct and indirect) and outcomes (health status and quality of life of both patients and caregivers) will
be compared. Indicators of socio-economic characteristics, perceived quality of life (Short Form-36, EORTC 29, 30), and
patients use of social and health care resources will be collected. Relevant caregivers' information will be acquired by ad
hoc questionnaire. Direct costs (e.g., enhancement of costs and nursing care workload related to prehabilitation protocol)
will be measured through the information collected by questionnaires. Indirect costs will be evaluated through two
alternative approaches: 1) replacement cost (revealed preferences or proxy good); 2) contingency evaluation based on data
collected by caregivers questionnaire. An analysis of the incremental cost-effectiveness ratio will be carried out over a 2-
year period.
Metodologies and statistical analyses:
We will conduct a single centre single blind randomized clinical trial. Patients will be randomized with a 1:1 allocation by
means of randomization software. We plan to enrol 112 patients, 56 per group. The sample size calculation was based on
the primary aim, the 6MWT. We used preliminary data from a sample (N=10) who underwent ERAS colonic resection for
cancer, evaluated at baseline and after a 4-week prehabilitation program with 6MWT. Mean baseline walking capacity was
571.5±64.1 meters, while following the 4-week prehabilitation program increased to 618.8±57.5 m with a mean change of
+47.2±57.5 m. We hypothesized that 8 weeks after surgery the difference in the 6MWT between the prehabilitation and the
control group would be about 45 m. Assuming a similar baseline walking capacity between the two study groups and an 8
weeks difference of about 45 ± 57 meters, with an alpha level of 0.05 a power of 80%, the required sample size is 51
patients per group. Assuming a 10% attrition we planned to enrol 112 patients. Univariate analyses will be conducted to
determine differences between groups on one time point with independent t-tests for continuous variables and chi-square
analyses for categorical variables. Generalized mixed models for repeated measure will be used to analyse the effect of the
prehabilitation program on several outcomes. Linear models will be used for continuous outcomes (primary research
question) and logistic models for dichotomous outcomes. Socio-demographic and clinical characteristics will be analysed as
time-invariant predictors.
Expected outcomes:
AIM 1. Better functional capacity (6MWT) in the experimental group (prehabilitation) at 8 weeks after surgery.
AIM 2. Decrease in postoperative complications due to the trimodal prehabilitation program.
AIM 3. Higher net social benefits for patients on prehabilitation compared to controls. We expect lower tangible costs and
higher effectiveness and better quality of life for patients and caregivers.
Risk analysis, possible problems and solutions:
- PATIENTS REFUSAL. Based on preliminary data, about 20% of patients may decline participation due to work
commitments or unwilling to exercise. Thus, we will enrol patients over a 30-month period. In a recent study on
implementation of an ERAS program for patients <81 years old undergoing bowel resection for colonic cancer at our
institution we enrolled about 40 patients/year. Thus, considering the wider age range and the inclusion of rectal cancer with
no preoperative treatment we are confident to reach the required sample. Some patients may fear to delay surgery, but the
usual wait at our institution for elective cancer surgery is about 5 weeks.
- LACK OF PATIENTS BLINDNESS. As patients in the study cannot be masked to the intervention, controls may increase
their physical activity awaiting for surgery due to the hypothesised potential benefit of prehabilitation. Thus, in order to
monitor this potential bias, we planned to objectively assess in both groups the amount of preoperative physical activity
using an accelerometer. These data may be helpful for the interpretation of the results.
5  /  33
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Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
- RISK OF OBSERVER BIAS. The assessors will be masked regarding the study group of the patients (single-blind study
design).
Significance and Innovation
Routine standard perioperative care currently does not include special nutrition, exercise and psychological anxiety support
before surgery. In colorectal patients undergoing surgery morbidity and mortality remains high with reduced physiological
and functional capacity. Patient lifestyle is a risk factor for cancer which may impair the nutritional status that in turn
aggravates deconditioning and muscle wasting, suggesting that improvement in both nutrition and functional exercise
capacity may be of benefit. Traditional approaches targeted the postoperative period for rehabilitation and lifestyle changes,
but postoperative complications are closely related to preoperative functional, nutritional and psychological status and the
preoperative period may be a better timeframe to intervene. Implementing a trimodal program targeting those problems
would represent a very innovative approach that, if beneficial, will promote a radical innovation in patients' preparation for
surgery.
The integrated activity of several distinct professionals with different and complementary scientific backgrounds is required.
A multidisciplinary prehabilitation team was constituted in 2016 integrating the ERAS group, including surgeons,
anaesthesiologists, and nurses with dietitians, a geriatrician experienced in sarcopenia and functional assessment, sports
medicine physicians and psycho-oncologists.
Formal meetings of the multidisciplinary prehabilitation group will be held on a monthly basis to revise and discuss the care
pathway of enrolled patients, analyse and solve potential problems.
Patients will be seen in the office by the surgeon following colorectal cancer diagnosis and screened for eligibility;
preoperative staging imaging will be prescribed and surgery will be scheduled approximately 4 weeks after the end of the
diagnostic work-up. Patients who provide informed consent for the study, will be randomized to either prehabilitation or
control group and will be sent to sports physician, for baseline evaluation. Patients allocated to prehabilitation will be also
evaluated by psycho-oncologist and dietician and will start the trimodal prehabilitation program. Patients in both study
groups will be reassessed the week before operation and at 4 and 8 weeks after surgery by the sports physician.
A specifically trained and dedicated research case manager will coordinate the research care protocol, including
assessments.
Description of the complementary and sinergy research team
6  /  33
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Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
The ERAS group visited in December 2014 the McGill University Health Centre in Montreal (CAN) where a perioperative
program including prehabilitation was investigated (https://www.mcgill.ca/peri-op-program/). A conference on Surgical
Prehabilitation was also attended at Mc Gill University in June 2017.  At that time, meetings with the local multidisciplinary
team (anesthesiologists, surgeons, nurses, kinesiologists, nutritionists) were held, and the organization as well as pattern of
prehabilitation was seen and discussed.
We then defined a prehabilitaion care protocol founded on the elements selected on available evidence of clinical efficacy.
Members of our prehabilitation team will formally visit the team at McGill University to further specialize on trimodal
prehabilitation, and will then share the training received with the other staff members.
The McGill team will provide support to the project also by discussing and analysing the data and difficulties throughout the
process.
Training and tutorial activities
1. Kirchhoff P et al. Complications in colorectal surgery: risk factors and preventive strategies. Patient Saf Surg 2010;4:5
2. McDermott FD et al. Systematic review of preoperative, intraoperative and postoperative risk factors for colorectal
anastomotic leaks. Br J Surg. 2015;102:462
3. Christensen T et al. Postoperative fatigue. World J Surg 1993;17:220
4. Kehlet H. Manipulation of the metabolic response in clinical practice. World J Surg 2000;24:690
5. Portinari and Feo CV. Impact of a colorectal enhanced recovery program implementation on clinical outcomes and
institutional costs: A prospective cohort study with retrospective control. Int J Surg 2018;53:206
6. Debes C et al. Prehabilitation. Preparing patients for surgery to improve functional recovery and reduce postoperative
morbidity. Ann Fr Anesth Reanim 2014;33:33
7. Carli F et al. Prehabilitation to improve recovery of physical function following colorectal surgery: A RCT. Br J Surg
2010;97:1187
8. Bolshinsky V, et al. Multimodal Prehabilitation Programs as a Bundle of Care in Gastrointestinal Cancer Surgery: A
Systematic Review. Dis Colon Rectum. 2018;61:124
9. Gillis C et al. Prehabilitation vs. rehabilitation: RCT in patients undergoing colorectal resection for cancer. Anesthesiology
2014;121:937
10. Pecorelli N et al. 6MWT as a measure of postoperative recovery after colorectal resection¿Surg Endosc 2016;30:2199
11. Grazzi G et al. Improved walking speed is associated with lower hospitalisation rates in patients in an exercise-based
secondary prevention programme. Heart 2016;102:1902
12. Spitzer RL et al. A brief measure for assessing generalized anxiety disorder: GAD-7. Arch Intern Med 2006;166:1092
13. Kroenke K et al. The PHQ-9: A new depression¿measure. Psychiatric Ann 2002;32:1
14. Dindo D et al. Classification of surgical complications: a new proposal... Ann Surg 2004;240:205
15. Slankamenac K et al. The CCI, a novel and more sensitive endpoint for assessing outcome... Ann Surg 2013;258:1
Bibliography
0-1 MONTH
Setting up:
Timeline / Deliverables / Payable Milestones
7  /  33
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Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
- Screening form for patients' selection and enrolment
- Form for baseline data collection
- Form for follow-up data collection
- Investigator's manual
2-3 MONTHS
  - Kick-off investigators' meeting
- Assessors recruitment and formal training
- Setting up electronic database
4-33 MONTHS
- Patients enrolment and delivery of interventions and assessments
- Electronic data entry
21-22 MONTHS
- Interim analysis
34-36 MONTHS
- Statistical analysis and manuscript drafting
1) Development of the dedicated web-based electronic database;
2) Enrolment of 40% (N=45) of scheduled patients for both study groups;
3) Complete follow-up and data entry for 25-30% of the patients enrolled.
Milestones 18 month
Milestones 36 month
1) Enrolment of 100% of scheduled patients (115 patients);
2) Complete follow-up assessment and electronic data entry for all the patients enrolled;
3) Complete statistical and cost-effectiveness data analysis;
4) First manuscript drafting.
Gantt chart
Gantt_RF-2018.pdf
8  /  33
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Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
1. Facilities Available
- SURGERY. Patients are usually seen before surgery in the preoperative clinic to determine if they are fit for surgery and
to adjust their medication. Routine standard perioperative clinical care at our institution currently do not include special
nutrition, exercise, and psychological support to cope with anxiety before surgery, but does include preoperative smoking
cessation and hematinic optimization (target hemoglobin level 11 g/dl). After surgery, they are not offered an in-hospital
exercise program, but are given generic instructions by the surgeons about mobilization and return to normal activities.
Some patients may be referred to a physiotherapist by their treating doctor. The introduction of interventional measures of
nutrition, exercise and coping strategies is solely for research purposes. A laparoscopic approach is elected for colorectal
cancer resection. Perioperative care is guided by a standardized multi-element evidence-based comprehensive ERAS
pathway following the consensus review on best care for patients undergoing colorectal surgery (Fearon KC, et al. Clin Nutr
2005;24:466-77).
- CENTRE FOR BIOCHEMICAL STUDIES APPLIED TO SPORTS MEDICINE UNIVERSITY OF FERRARA - AZIENDA
USL FERRARA. Experienced centre for development, validation and implementation of comprehensive personalized
protocols of physical activity for patients with several diseases including cardiovascular, metabolic and neurological
diseases. The facility is equipped with all the instruments required for the evaluation of functional exercise capacity,
including CPET.
- CENTRE FOR CLINICAL EPIDEMIOLOGY UNIVERSITY OF FERRARA. Experienced centre for the design and
conduction of clinical studies including RCTs and for biostatistical analysis with quality data control. The centre includes a
methodologist for clinical study (MPH degree) and a biostatistician with a postgraduate degree in biostatistics.
2. Subcontract
- RESEARCH CENTRE ON HEALTH MANAGEMENT UNIVERSITY OF FERRARA. An economist expert in health
management is included in the research team in order to plan and conduct the cost-effectiveness and efficacy analysis.
- DIETITIAN. As part of the trimodal prehabilitaiton intervention, patients will be evaluated perioperatively (at baseline,
immediately before surgery and at 4 and 8 weeks after surgery) by a dietician for nutritional status assessment and
nutritional supplementation if needed.
Equipment and resources available
9  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Translational relevance and impact for the National Health System (SSN)
Trimodal prehabilitation can greatly affect the quality of care within the SSN affecting three dimensions:
1) THE STRUCTURE (where health care is delivered). Better postoperative physical function, reduced morbidity and length
of hospital stay should decrease both hospital and social costs as well as support from other health-care institutions
(nursing homes, family doctors). In addition, waiting lists in public hospitals might be shortened as rapid turnover yields
increasing bed availability. Optimized performance and use of resources may provide financial benefits to the hospital,
stimulating a wider application of such methodology within the SSN;
2) THE PROCESS (care received). Better physical function, reduced morbidity, accelerated recovery may all improve the
quality of care;
3) THE OUTCOMES (mortality, morbidity, length of stay). Trimodal prehabilitation may improve the outcome of patients by
decreasing postoperative morbidity, promoting safety and improving quality of life.
10  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
PRINCIPAL INVESTIGATOR PROFILE
Name
Institution
Position Title
Department/Unit
FEO CARLO
Emilia-Romagna
Department of Surgery/U.O. Chirurgia Generale
Provinciale
Chief, U.O. Chirurgia Generale Provinciale;
Associate professor
Personal Statement
- To implement a trimodal prehabilitation program (physical exercise, psychological support and nutritional optimization) in
patients undergoing ERAS colorectal resection for cancer with standard rehabilitation, expecting better physical
performance at 8 weeks after surgery, decreased postoperative complications, and reduced direct and indirect costs
compared to controls (patients undergoing ERAS colorectal resection for cancer with standard rehabilitation and NO
prehabilitation).
- Conception of the study and research hypothesis, enroll and operate on patients, coordination of the study.
Education/Training - Institution and Location
Degree
Year(s)
Field of study
School of Medicine, University of Sassari, Sassari (Italy)
Medical Doctor (M.D.)
1991
Medicine and Surgery
University of Ferrara and Department of Surgery Azienda Ospedaliero-
Universitaria di Ferrara, Ferrara, Italy
Residency in General
Surgery, Board certified
in General Surgery
1996
General Surgery
Department of Surgery, University of California San Francisco (UCSF), San
Francisco (USA)
Research fellowship
1996
Pathophysiology and
surgical treatment of
gastro-oesophageal reflux
disease and primayi
motility disorders of the
oesophagus.
Department of Surgery, University of California San Francisco (UCSF), San
Francisco (USA)
Clinical fellowship
1998
Advanced laparoscopic
surgery
University of Bologna, Bologna (Italy)
Master degree
2015
Health policy
11  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Positions
Institution
Division / Research
group
Location
Position
From
year
To
year
Azienda Ospedaliero-
Universitaria di Ferrara
UO Clinica Chirurgica
Ferrara, Italy
Assistant surgeon
1999
1999
Azienda Ospedaliero-
Universitaria di Ferrara
UO Clinica Chirurgica
Ferrara Italy
Consultant
1999
2002
University of Ferrara
UO Clinica Chirurgica
Ferrara, Italy
Assistant professor
2002
2011
Azienda Ospedaliero-
Universitaria di Ferrara
UO Clinica Chirurgica
Ferrara, Italy
Attending
2002
2017
University of Ferrara
UO Clinica Chirurgica
Ferrara, Italy
Associate professor
2011
2018
Azienda USL di Ferrara
U.O. Chirurgia Generale
Provinciale
Ferrara, Italy
Chief
2017
2022
Official H index:
20.0
Source:
Scopus
Scopus Author Id: 7006128539
ORCID ID: 0000-0003-0699-568
RESEARCH ID:
K-5134-2016
( autocertificated )
Awards and Honors:
Other CV Informations:
1999: Research scholarship Azienda Ospedaliera di Ferrara
2010-Present: Fellow American College of Surgeons
2011-13, 2018-20: Vice-President Società Medico Chirurgica di Ferrara
2012-17: Member Board of Research Azienda Ospedaliero-Universitaria di Ferrara
2015: Best session poster at Euroanesthesia 2015, Berlin (D)
2016-18: Educational Dean School of Nursing University of Ferrara
REVIEWER of journals (eg, Lancet, Ann Surg) and EDITORIAL BOARD of World J Gastrointest Surg, J Lap Adv Surg Tech
1991: Medical Doctor degree cum laude
1996: Educational Commission Foreign Medical Graduate (ECFMG) Standard Certificate valid indefinitely
1996: Research fellow, Deparment of Surgery University of California San Francisco (UCSF), USA
1996-1998: Clinical fellow, Deparment of Surgery UCSF
2006-Present: Instructor Advanced Trauma Life Support
1997-2005: Member Society American Gastrointestinal Endoscopic Surgeons (SAGES)
1997-2010: Member Society Surgery Alimentary Tract (SSAT)
2006-Present: Member European Association Endoscopic Surgeons (EAES)
2013-2014, 2015-2016: Director Postgraduate course in OR Surgical Nursing, University of Ferrara
2013, 2018: National Academic Qualification as Full Professor of Surgery
12  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Valid for PI minimum expertise level
Title
DOI
PMID
Cit. **
P.*
Laparoscopic approach for esophageal achalasia with epiphrenic diverticulum. Surgical
Laparoscopy, Endoscopy and Percutaneous Techniques 2001;11:112-115
10.1097/00019509-
200104000-00009
11330375
7 F
The ideal leght of hospital stay in the surgical treatment of colo-rectal cancer. Annali Italiani di
Chirurgia 2002;73:13-16
12148416
4 F
Early oral feeding after colorectal resection: a randomized controlled study. ANZ J Surg.
2004;74:298-301
15144242
67 F
Preoperative dexamethasone improves postoperative nausea and vomiting following laparoscopic
cholecystectomy: A randomised controlled trial. Br J Surg 2006;95:295-299
10.1097/CEJ.0b013e
3283429ea3
16400707
57 F
Fast track postoperative management for patients undergoing elective colorectal resections: A
controlled trial
Am Surgeon 2009;75:1247-1251
19999921
14 F
The first 2 years of colorectal cancer screening in Ferrara, Italy. Eur J Cancer Prev 2011;20:166-
168
10.1097/CEJ.0b013e
3283429ea3
21445018
3 C
Minimally invasive myotomy for the treatment of esophageal achalasia: The evolution of the
surgical procedure and of therapeutic algorithm. Surg Laparosc Endosc Percutan Tech
2012;22:
83-87
10.1097/SLE.0b013e
318243368f
22487617
5 L
Esophageal achalasia with recurrent aspiration pneumoniae treated by laparoscopic Heller
myotomy. Am Surgeon 2012;78:168-170
22524750
0 F
Radio-guided selective compartment neck dissection improves staging in papillary thyroid
carcinoma: a prospective study on 345 patients with a 3-year follow-up. Surgery 2014;156:147-157
PMID:
10.1016/j.surg.2014.0
3.045
24929764
6 L
Preoperative endoscopic tattooing to mark the tumour site does not improve lymph node retrieval in
colorectal cancer: a retrospective cohort study. J Negat Results Biomed 2015;14:9
10.1186/s12952-015-
0027-7
25947298
2 F
Applicability of laparoscopic approach to the resection of large adrenal tumours: A retrospective
cohort study on 200 patients. Surg Endosc 2016;30:3532-3540.
10.1007/s00464-015-
4643-6
26541739
1 F
The impact of an Enhanced Recovery Program in elective retroperitoneal abdominal aortic
aneurism repair: A retrospective cohort study on 221 patients. J Vasc Surg 2016;63:888-894
10.1016/j.jvs.2015.09
.060
26806521
4 F
Laparoscopic versus open incisional hernia repair: A retrospective cohort study with costs analysis
on 269 patients. Hernia 2017;21:609-618
10.1007/s10029-017-
1601-3
28396956
1 L
Impact of a colorectal enhanced recovery program implementation on clinical outcomes and
institutional costs: a prospective cohort study with retrospective conrol. Int J Surg 2018;203: 206-
213
10.1016/j.ijsu.2018.0
3.005
29548700
0 L
* Position: F=First  L=Last  C=Corrispondent
Selected peer-reviewed publications of the PI
** Autocertificated
13  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
For evaluation CV
Title
DOI
PMID
Cit. *
Importance of pre- and postoperative pH monitoring in patients with esophageal achalasia. J
Gastrointest Surg 1997;1:505-510
9834385
66
Comparison of laparoscopic and thoracoscopic Heller myotomy for achalasia. J Gastrointest Surg
1998;2:561-566
10457314
71
Laparoscopic repair of paraesophageal hiatal hernias. J Am Coll Surg 1998;186:428-432
9544957
83
An analysis of operation for GERD: Identifying the important technical elements. Arch Surg
1998;113:600-607
9637457
75
Laparoscopic Heller myotomy relieves dysphagia in achalasia when the esophagus is dilated. Surg
Endosc 1999;13:843-847
10449836
72
The effects of previous treatment on the results of laparoscopic Heller myotomy for achalasia. Dig Dis
Sci 1999;44:2270-2276
10573373
116
Effect of laparoscopic fundoplication on gastroesophageal reflux disease-induced respiratory symptoms.
J Gastrointest Surg 2000;4:143-149
10675237
82
Preoperative dexamethasone improves postoperative nausea and vomiting following laparoscopic
cholecystectomy: A randomised controlled trial. Br J Surg 2006;93:295-299
10.1002/bjs.5252
16400707
57
Intrathoracoscopic localization techniques. Review of literature. Surg Endosc 2006;20:1341- 1347
10.1007/s00464-005-
0407-z
16703435
26
Clinical and therapeutic importance of sentinel node biopsy of the internal mammary chain in patients
with breast cancer: a single-center study with long-term follow-up. Ann Surg Oncol 2006;13:1338-1343
10.1245/s10434-006-
9062-4
16952022
38
* Autocertificated
Grant
Funded Institution / Country
Year
Title
Position in Projects
Ministery of Health
2012-
2016
The implementation of an enhanced recovery program (fast
track) after colorectal resection for colonic cancer  Coordinator.
Coordinator
Employment contract extension:
14  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Biographical Sketch Contributors 1
Name:
Institution
Position Title
Department/Unit
Azienda Usl di Ferrara - Emilia-Romagna
Department of Sport Medicine/Division of Excercise
and Sports Medicine - Azienda USL di Ferrara
Attending, Program coordinator
Grazzi Giovanni
Education/Training - Institution and Location
Degree
Year(s)
Field of study
University of Ferrara
Medical Doctor (M.D.)
1983
Medicine and Surgery
University of Chieti
Residency in sports
medicine, Board certified
in sports medicine
1986
Sports Medicine
Personal Statement:
- To implement a trimodal prehabilitation program (physical exercise, psychological support and nutritional optimization) in
patients undergoing ERAS colorectal resection for cancer with standard rehabilitation, expecting better physical
performance at 8 weeks after surgery, decreased postoperative complications, and reduced direct and indirect costs
compared to controls (patients undergoing ERAS colorectal resection for cancer with standard rehabilitation and NO
prehabilitation).
- Prehabilitation of patients.
Institution
Division / Research
group
Location
Position
From
year
To
year
Italian Olympic Committee
Centre for Biochemical
studies applied to Sports
Medicine, University of
Ferrara - Azienda USL of
Ferrara
Ferrara, Italy
Research fellow
1984
1990
Italian National Health Care
System
USL n. 32 (Emilia-Romagna)
e ULSS 21 (Veneto)
Ferrara and Legnago, Italy
Sports Medicine physician
1992
2003
Azienda Ospedaliero-
Universitaria di Ferrara
Cardiac rehabilitation
program
Ferrara, Italy
Sports Medicine Physician
1997
2001
University of Ferrara
Department of Biomedical
and Surgical Specialization
Sciences
Ferrara, Italy
Assistant Professor of Sports
Medicine
2004
2018
15  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Awards and Honors
Official H index:
9.0
Source:
Scopus
Scopus Author Id: 6505775983
ORCID ID: 0000-0001-9649-8875
RESEARCH ID:
K-5391-2016
( autocertificated )
Awards and Honors:
- 2012, 2014: Award as best scientific presentation at National meeting of Italian Group of Cardiac Rehabilitation
- 2005: National patent
16  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Biographical Sketch Contributors 2
Name:
Institution
Position Title
Department/Unit
Azienda Ospedaliero-Universitaria di Ferrara -
Emilia-Romagna
Department of Medicine/Division of Internal
Medicine/Center for Clinical Epidemiology - Azienda
Ospedaliero-Universitaria di Ferrara
Attending physician, Associate Professor
VOLPATO STEFANO
Education/Training - Institution and Location
Degree
Year(s)
Field of study
University of Ferrara, Ferrara, Italy
Medical Doctor (MD)
1991
Medicine and Surgery
University of Ferrara, School of Medicine, Ferrara, Italy
Residency in
Endocrinology and
Metabolic disease
Board in Endocrinology
and Metabolic disease
1997
Endocrinology and
Metabolism
Johns Hopkins University, School of Hygiene and Public Health, Bethesda,
Maryland
Master in Public Health
1999
Epidemiology,
Biostatistics, Clinical
studies, including clinical
trails
University of Padova, School of Medicine, Padua, Italy
Residency in Geriatrics,
Board certified in
Geriatrics
2006
Geriatrics and
Gerontology
Personal Statement:
- To implement a trimodal prehabilitation program (physical exercise, psychological support and nutritional optimization) in
patients undergoing ERAS colorectal resection for cancer with standard rehabilitation, expecting better physical
performance at 8 weeks after surgery, decreased postoperative complications, and reduced direct and indirect costs
compared to controls (patients undergoing ERAS colorectal resection for cancer with standard rehabilitation and NO
prehabilitation).
- Design and implemementation of the study and statistical analysis.
17  /  33
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Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Institution
Division / Research
group
Location
Position
From
year
To
year
University of Ferrara,
Azienda Ospedaliero-
Univerisitaria di Ferrara
Department of Medicine
Ferrara
Clinical Staff Fellow
1997
1998
National Institute on Aging,
National Institutes of Health
Epidemiology, Demography,
and Biometry Program
Bethesda, Maryland, USA
Research Fellow
1999
2001
University of Ferrara,
Azienda Ospedaliero-
Universitaria di Ferrara
Department of medical
Sciences
Ferrara, Italy
Assistant professor
2001
2014
University of Ferrara,
Azienda Ospedaliero-
Universitaria di Ferrara
Department of medical
Sciences
Ferrara, Italy
Associate Professor
2014
2018
Awards and Honors
Official H index:
47.0
Source:
Scopus
Scopus Author Id: 35330577100
ORCID ID: 0000-0003-4335-6034
RESEARCH ID:
H-2977-2014
( autocertificated )
Awards and Honors:
1991: Graduated Magna Cum Laude, University of Ferrara
1997: Scholarship by Arlotti Foundation, Italy, for the research project: "Epidemiological study of disability and
correlated metabolic diseases in the elderly"
2005: Award as young researcher for the best scientific article in the 2003-2005 period. Italian Foundation for Aging
Research (F.I.R.I) in the 2003-2005 period.
2009: Fellow of the Gerontological Society of America
2014: Highly Cited Researcher (Thompson Reuters-Social Sciences)
18  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Biographical Sketch Contributors 3
Name:
Institution
Position Title
Department/Unit
Azienda Ospedaliero-Universitaria di Ferrara -
Emilia-Romagna
Department of Surgery/U.O. Chirurgia 2 - Azienda
Ospedaliero-Universitaria di Ferrara
Attending
DE TROIA ALESSANDRO
Education/Training - Institution and Location
Degree
Year(s)
Field of study
School of Medicine, University of Ferrara, Ferrara, Italy
Medica Doctor (M.D.)
2008
Medicine and Surgery
University of Ferrara and Department of Surgery Azienda Ospedaliero-
Universitaria di Ferrara, Ferrara, Italy
Residency in General
surgery
Board certified in
General Surgery
2015
General Surgery
University of Ferrara and Department of Surgery Azienda Ospedaliero-
Universitaria di Ferrara, Ferrara, Italy
Research Fellowship
2016
Intraoperative
radiotherapy in breast
cancer surgery
Personal Statement:
- To implement a trimodal prehabilitation program (physical exercise, psychological support and nutritional optimization) in
patients undergoing ERAS colorectal resection for cancer with standard rehabilitation, expecting better physical
performance at 8 weeks after surgery, decreased postoperative complications, and reduced direct and indirect costs
compared to controls (patients undergoing ERAS colorectal resection for cancer with standard rehabilitation and NO
prehabilitation).
- Screening and enrollment of elegibile patients.
Institution
Division / Research
group
Location
Position
From
year
To
year
University of Ferrara
U.O. Clinica Chirurgica -
Azienda Ospedaliero-
Universitaria di Ferrara
Ferrara, Italy
Research and Clinical Fellow
2015
2016
Awards and Honors
Official H index:
1.0
Source:
Scopus
Scopus Author Id: 57200918030
ORCID ID: 0000-0002-0078-3303
RESEARCH ID:
K-7691-2016
( autocertificated )
Awards and Honors:
- 2008: Degree in Medicine and Surgery University of Ferrara Italy 110/110 cum laude
- 2010: Winner of the "Premio di Studio di ricerca in oncologia E.Zanetti "- Graduate Thesis in Oncology
- 2016: Research Collaborator (Enrollment - Methodologist) in RF -2013-02358165 "Axillary Reverse Mapping (ARM). Try
to identify and spare lymphatic pathways in breast cancer surgery to prevent breast cancer related lymphedema (BCRL)" P.
19  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
I. Prof. P. Carcoforo, founded by Italian Ministry of Health
20  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Biographical Sketch Contributors 4
Name:
Institution
Position Title
Department/Unit
Emilia-Romagna
Department of Mental Health/Division of Psychiatry
- Azienda USL di Ferrara
Evaluate and treat mood and psychological
disorders of the patients
CARUSO ROSANGELA
Education/Training - Institution and Location
Degree
Year(s)
Field of study
University of Ferrara, Ferrara, Italy
Medical Doctor (M.D.)
2004
Medicine and Surgery
University of Ferrara
Residency in Psychiatry,
Board certified in
Psychiatry
2008
Psychiatry
Personal Statement:
- To implement a trimodal prehabilitation program (physical exercise, psychological support and nutritional optimization) in
patients undergoing ERAS colorectal resection for cancer with standard rehabilitation, expecting better physical
performance at 8 weeks after surgery, decreased postoperative complications, and reduced direct and indirect costs
compared to controls (patients undergoing ERAS colorectal resection for cancer with standard rehabilitation and NO
prehabilitation).
- Evaluate and treat mood and psychological disorders of the enrolled patients with colorectal cancer.
Institution
Division / Research
group
Location
Position
From
year
To
year
University of Ferrara
Department of Biomedical
Sciences and Surgical
Specialties
Ferrara
Resident in Psychiatry
2007
2012
University of Ferrara
Department of Biomedical
Sciences and Surgical
Specialties
Ferrara
PhD Candidate
2012
2014
University of Ferrara -
Azienda USL di Ferrara
Department of Biomedical
Sciences and Surgical
Specialties/ Department of
Mental Health
Ferrara
Assistant Professor/Psychiatrist
2015
2018
21  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Awards and Honors
Official H index:
9.0
Source:
Scopus
Scopus Author Id: 36623259500
ORCID ID: 0000-0002-6662-2270
RESEARCH ID:
L-4254-2016
( autocertificated )
Awards and Honors:
- Member of the Psycho-Oncology Italian Association (SIPO)
- Member of the Italian Consultation Psichiatry Society (SIPC)
- Founding member of the Italian Cognitive-Analytic Therapy Association (ITACAT)
22  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Selected peer-reviewed publications of the Research Group / Collaborators
Collaborator
Title
DOI
PMID
Cit. *
Grazzi
Giovanni
Home-centred physical fitness programme in morbidly obese individuals: a randomized
controlled trial. Clin Rehabil 2008; 22:940-950
10.1177/0
26921550
8092788
18955426
10
VOLPATO
STEFANO
Predictive value of the Short Physical Performance Battery following hospitalization in older
patients. J Gerontol A Biol Sci Med Sci. 2011;66:89-96
10.1093/gerona/
glq167
20861145
116
CARUSO
ROSANGELA
Educational Intervention in cancer outpatients clinics on routine screening for emotional
distress: an observational study. Psychooncology 2011;20:669-674
10.1002/pon.194
4
21370316
31
VOLPATO
STEFANO
Role of muscle mass and muscle quality in the association between diabetes and gait speed.
Diabetes Care 2012;35:1672-1679
10.2337/dc11-
2202
22596176
82
VOLPATO
STEFANO
Handgrip strength predicts persistent walking recovery after hip fracture surgery. Am J Med
2013;126:1068-1075
10.1016/j.amjme
d.2013.04.017
24054175
23
Grazzi
Giovanni
Association between VO¿ peak estimated by a 1-km treadmill walk and mortality. Int J
Cardiol 2014;173:248-252
10.1016/j.i
jcard.2014.02.03
24630380
10
VOLPATO
STEFANO
Volpato S, Guralnik JM. Hip fractures: comprehensive geriatric care and recovery. Lancet.
2015;385:1594-1595
10.1016/S0140-
6736(14)61592-
0
25662417
4
CARUSO
ROSANGELA
Role of Psychosocial Variables on chemotherapy-induced nausea and vomiting and health-
related quality of life among cancer patients. A European Study. Psychother Psychosom
2015;84:339-347
10.1159/000431
256
26402426
16
Grazzi
Giovanni
Improved walking speed is associated with lower hospitalisation rates in patients in an
exercise-based secondary prevention programme. HEART 2016;102:1902-1908
10.1136/heartjnl-
2015-309126
27390367
8
VOLPATO
STEFANO
Prevalence and Clinical Correlates of Sarcopenia, Identified According to the EWGSOP
Definition and Diagnostic Algorithm, in Hospitalized Older People: The GLISTEN Study J
Gerontol A Biol Sci Med Sci,2017;72:1575-1581
10.1093/gerona/
glw343
28329345
5
Expertise Research Collaborators
* Autocertificated
23  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Grant
Funded Institution / Country
Year
Title
Position in
Projects
Collaborator
Istituto Oncologico Romagnolo, Forlì Italy
2010-
2012
Relational and psychosocial variables connected with
adherence to therapies antiemetic during chemotherapy
- FUND GRANT:€10.000
Collaborator
VOLPATO
STEFANO
Programma di Ricerca Regione- Università
2010-2012: Area 1 Ricerca Innovativa
Programma Strategico area 1
2013
Role of Rehabilitation after cerebral and myocardial
damage - FUND GRANT: €27000
Collaborator
VOLPATO
STEFANO
 Programma CCM (CENTRO NAZIONALE PER
LA PREVENZIONE E IL CONTROLLO DELLE
MALATTIE)
2013
Implementazione di un modello organizzativo integrato
per la gestione del paziente con demenza: dalla
prevenzione alla cura con presa in carico - POSITION IN
PROJECT: Local PI - FUND GRANT: €49.000
Coordinator
VOLPATO
STEFANO
Regione Emilia Romagna - Programma di
Ricerca Regione-Università 2014 - Area 3
FORMAZIONE ALLA RICERCA E CREAZIONE
DI RESEARCH NETWORK
2014
Formazione di una rete statistica aziendale per il
supporto alla ricerca biomedica - FUND GRANT:
€83.000
Coordinator
VOLPATO
STEFANO
Italian Ministry of Health
2016
RF -2013-02358165: Axillary Reverse Mapping (ARM).
Try to identify and spare lymphatic pathways in breast
cancer surgery to prevent breast cancer related
lymphedema (BCRL)
Collaborator
DE TROIA
ALESSANDRO
H2020-HEALTH
2017
EUROlinkCAT: Establishing a linked European Cohort of
Children with Congenital Anomalies - POSITION IN
PROJECT: Local PI - FUND GRANT: €343.217
Coordinator
VOLPATO
STEFANO
24  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Total proposed budget ( Euro )
Costs
TOTAL BUDGET
Co-Funding
List of costs proposed for
funding to the MOH
Percentage of
total proposed
to the MOH
1a Staff Salary
270.000,00
0,00
1b Researchers' Contracts
174.000,00
0,00
174.000,00
48,33
2 Equipment (Leasing - Rent)
130.000,00
90.000,00
40.000,00
11,11
3a Supplies
30.900,00
0,00
30.900,00
8,58
3b Model Costs
0,00
0,00
0,00
0,00
3c Subcontracts
30.100,00
0,00
30.100,00
8,36
3d Patient Costs
0,00
0,00
0,00
0,00
4 IT Services and Data Bases
10.000,00
0,00
10.000,00
2,78
5 Publication Costs
6.000,00
0,00
6.000,00
1,67
6 Convegni
3.000,00
0,00
3.000,00
0,83
7 Travels
6.000,00
0,00
6.000,00
1,67
8 Overheads
30.000,00
0,00
30.000,00
8,33
9 Coordination Costs
30.000,00
0,00
30.000,00
8,33
Total
720.000,00
360.000,00
360.000,00
100,00
Report the Co-Funding Contributor:
Staff salary: PI,CO-PI and all collaborators
Equipment: depreciation of the equipment value
25  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Budget Justification
1a Staff Salary
salary Pi, Co-PI, RUO and other collaborators
1b Researchers' Contracts
contracts for the management of the whole study workup
2 Equipment (Leasing - Rent)
depreciation of equipment value -
specific equipment for the study: Accelerometer x 10, Bioelectrical impedance analyser x 2 for body composition
analysis, Manual idraulic dynamometer x 2 for grip strength evaluatation, laptops for real time data entry
3a Supplies
consumables and devices useful for the successful completion of the project
3b Model Costs
none
3c Subcontracts
this budget will cover expences for economical analysis and nutritional evaluation of patients on prehabilitation
3d Patient Costs
none
4 IT Services and Data Bases
software related to the development of the project
5 Publication Costs
abstract submission for interim results and full papers for final results
6 Convegni
partecipation in workshop to disseminate results
7 Travels
travels will be needed to attend pertinent meeting of specific interest to the project
8 Overheads
general costs generated to project management
9 Coordination Costs
logistic costs relating to data presentation at meeting and congresses
26  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Proposed total budget UO1 Institution: Emilia-Romagna (Euro)
Costs
TOTAL BUDGET
Co-Funding
List of costs proposed for
funding to the MOH
Percentage of
total proposed
to the MOH
1a Staff Salary
90.000,00
0,00
1b Researchers' Contracts
84.000,00
0,00
84.000,00
35,99
2 Equipment (Leasing - Rent)
130.000,00
90.000,00
40.000,00
17,14
3a Supplies
16.400,00
0,00
16.400,00
7,03
3b Model Costs
0,00
0,00
0,00
0,00
3c Subcontracts
18.000,00
0,00
18.000,00
7,71
3d Patient Costs
0,00
0,00
0,00
0,00
4 IT Services and Data Bases
10.000,00
0,00
10.000,00
4,28
5 Publication Costs
6.000,00
0,00
6.000,00
2,57
6 Convegni
3.000,00
0,00
3.000,00
1,29
7 Travels
6.000,00
0,00
6.000,00
2,57
8 Overheads
20.000,00
0,00
20.000,00
8,57
9 Coordination Costs
30.000,00
0,00
30.000,00
12,85
Total
413.400,00
180.000,00
233.400,00
100,00
Report the Co-Funding Contributor:
27  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Budget Justification
1a Staff Salary
salary PI,  and other collaborators
1b Researchers' Contracts
contracts for the management of the whole study workup
2 Equipment (Leasing - Rent)
depreciation of equipment value
specific equipment for the study: Accelerometer x 10, Bioelectrical impedance analyser x 2 for body composition
analysis, Manual idraulic dynamometer x 2 for grip strength evaluatation, laptops for real time data entry
3a Supplies
consumables and devices useful for the successful completion of the project
3b Model Costs
none
3c Subcontracts
this budget will cover expences for economical analysis and nutritional evaluation of patients on prehabilitation
3d Patient Costs
none
4 IT Services and Data Bases
software related to the development of the project
5 Publication Costs
abstract submission for interim results and full papers for final results
6 Convegni
partecipation in workshop to disseminate results
7 Travels
travels will be needed to attend pertinent meeting of specific interest to the project
8 Overheads
general costs generated to project management
9 Coordination Costs
logistic costs relating to data presentation at meeting and congresses
28  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Proposed total budget UO2 Institution: Azienda Usl di Ferrara - Emilia-Romagna (Euro)
Costs
TOTAL BUDGET
Co-Funding
List of costs proposed for
funding to the MOH
Percentage of
total proposed
to the MOH
1a Staff Salary
90.000,00
0,00
1b Researchers' Contracts
60.000,00
0,00
60.000,00
66,67
2 Equipment (Leasing - Rent)
0,00
0,00
0,00
0,00
3a Supplies
14.500,00
0,00
14.500,00
16,11
3b Model Costs
0,00
0,00
0,00
0,00
3c Subcontracts
8.500,00
0,00
8.500,00
9,44
3d Patient Costs
0,00
0,00
0,00
0,00
4 IT Services and Data Bases
0,00
0,00
0,00
0,00
5 Publication Costs
0,00
0,00
0,00
0,00
6 Convegni
0,00
0,00
0,00
0,00
7 Travels
0,00
0,00
0,00
0,00
8 Overheads
7.000,00
0,00
7.000,00
7,78
9 Coordination Costs
0,00
Total
180.000,00
90.000,00
90.000,00
100,00
Report the Co-Funding Contributor:
29  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Budget Justification
1a Staff Salary
salary co-PI
1b Researchers' Contracts
contracts for the management of the whole study workup
2 Equipment (Leasing - Rent)
none
3a Supplies
consumables and devices useful for the successful completion of the project
3b Model Costs
none
3c Subcontracts
this budget will cover expences for economical analysis and nutritional evaluation of patients on prehabilitation
3d Patient Costs
none
4 IT Services and Data Bases
none
5 Publication Costs
none
6 Convegni
none
7 Travels
none
8 Overheads
general costs generated to project management
9 Coordination Costs
none
30  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Proposed total budget UO3 Institution: Azienda Ospedaliero-Universitaria di Ferrara -
Emilia-Romagna (Euro)
Costs
TOTAL BUDGET
Co-Funding
List of costs proposed for
funding to the MOH
Percentage of
total proposed
to the MOH
1a Staff Salary
90.000,00
0,00
1b Researchers' Contracts
30.000,00
0,00
30.000,00
81,97
2 Equipment (Leasing - Rent)
0,00
0,00
0,00
0,00
3a Supplies
0,00
0,00
0,00
0,00
3b Model Costs
0,00
0,00
0,00
0,00
3c Subcontracts
3.600,00
0,00
3.600,00
9,84
3d Patient Costs
0,00
0,00
0,00
0,00
4 IT Services and Data Bases
0,00
0,00
0,00
0,00
5 Publication Costs
0,00
0,00
0,00
0,00
6 Convegni
0,00
0,00
0,00
0,00
7 Travels
0,00
0,00
0,00
0,00
8 Overheads
3.000,00
0,00
3.000,00
8,20
9 Coordination Costs
0,00
Total
126.600,00
90.000,00
36.600,00
100,00
Report the Co-Funding Contributor:
31  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Budget Justification
1a Staff Salary
salary UO collaborators
1b Researchers' Contracts
contracts for the management of the whole study workup
2 Equipment (Leasing - Rent)
none
3a Supplies
none
3b Model Costs
none
3c Subcontracts
this budget will cover expences for economical analysis and nutritional evaluation of patients on prehabilitation
3d Patient Costs
none
4 IT Services and Data Bases
none
5 Publication Costs
none
6 Convegni
none
7 Travels
none
8 Overheads
general costs generated to project management
9 Coordination Costs
none
32  /  33
20/05/2018 19.06
Sent date:

Project Type: Ordinary/Progetti ordinari di Ricerca Finalizzata
Project Code:
Principal Investigator:
Applicant Institution:
Project Title:
RF-2018-12367272
FEO CARLO
Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and
lower postoperative complications: A randomized clinical trial.
Emilia-Romagna
Research Type:
b) Change-promoting: valutare la
sicurezza, efficacia, costo-efficacia, di
trattamenti/tecnologie/interventi
sanitari per cui sussistano significativi
margini di incertezza relativamente
agli aspetti menzionati, anche con
studi clinici di fase 3 e 4
BANDO RICERCA FINALIZZATA 2018
esercizio finanziario anni 2016-2017
Principal Investigator Data
Cognome: FEO
Nome: CARLO
Codice fiscale: FEOCRL66P06L219W
Documento: Passaporto, Numero: YA51007478
Data di nascita: 06/09/1966
Luogo di nascita: TORINO
Provincia di nascita: TO
Indirizzo lavorativo: VIA CASSOLI 30
Città: FERRARA
CAP: 44121
Provincia: FE
Email: carlo.feo@unife.it
Telefono: 3346499497
Qualifica: DIRETTORE STRUTTURA COMPLESSA - UO  CHIRURGICA GENERALE PROVINCIALE
Struttura: U.O. CHIRURGIA GENERALE PROVINCIALE -DIPARTIMENTO CHIRURGICO - AUSL Ferrara
Istituzione: REGIONE EMILIA-ROMAGNA - AZIENDA USL
33  /  33
20/05/2018 19.06
Sent date: