Fast-track in Minimally Invasive Gynaecology: a Randomized Trial Comparing Costs and Clinical Outcomes
Phase: NA
Conditions: Gynecologic Disease
Sponsor: University Hospital, Geneva

 
 « Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
Service de Gynécologie 
30 Bd de la Cluse  
 
1211 Genève 
Tél : 022 372 68 16 
 
   
 
 
 
 
 
“Fast track” surgery on patient undergoing 
minimally invasive gynaecologic procedure: a 
randomized clinical trial 
 
 
 
SEPTEMBER 29TH 2015 
VERSION 2.0 
 
 
 
 
 
MAIN INVESTIGATOR 
LAMBAT EMERY SHAHZIA 
 
 
CO-INVESTIGATORS 
PETIGNAT PATRICK 
BROSSARD PHILIPPE 
DALLENBACH PATRICK 
DUBUISSON JEAN 
WENGER JEAN-MARIE 
BOULVAIN MICHEL 
BRIET VIRGINIE 
 
 
RESEARCH NURSES 
ROYANNEZ DREVARD ISABELLE 
GUILLOT CECILE 
 
 
 
 

 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
2 
 
“Fast track” surgery on patient undergoing minimally invasive 
gynaecologic procedure: a randomized clinical trial 
 
 
Introduction: 
The concept of "enhanced recovery" was developed by American cardiologists in the 1950s to 
improve patient rehabilitation after a myocardial infarction. In 1995, this concept was extended to 
colonic surgery by Kehlet et al. who developed a perioperative multimodal strategy currently 
known as 'Fast track' (FT), or " Enhanced recovery after surgery ' (ERAS).1 This innovative concept 
suggests including the combination of minimally invasive surgery, analgesia optimization, early 
oral refeeding and rapid mobilization of patients which reduces pain and organic dysfunction 
induced by surgical stress. This concept, increasingly applied worldwide in colorectal surgery, has 
also shown efficiency by reducing hospitalization lenght.2.3 Gynaecological surgery, similar to 
colonic surgery in many ways, has very little explored this concept. 
The concept of “Fast track” or “Enhanced recovery after surgery”: 
FT is a global perioperative approach aiming to optimize patient care by early rehabilitation. The 
objectives are to reduce post-operative pain and organic dysfunction induced by surgical stress. 
This strategy facilitates recovery and comfort of patients while decreasing morbidity, 
hospitalization length and costs.3-5 This multimodal approach requires a close and well codified 
multidisciplinary collaboration in between surgeons, anaesthetists and the nursing team. The key 
elements of the program include preoperative patient information and education, lack of 
digestive preparation, perioperative water balance, analgesia optimization, early oral refeeding 
and rapid mobilization of patients.5-7 These elements can be classified into four subgroups in 
terms of overall support: 1) patient information and education, 2) preoperative, 3) perioperative 
and 4) postoperative (Figure 1).  
 
 
 
 
 

 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
3 
 
Figure 1 
                 
 
Surgical stress 
reduction
Surgeons
Anesthetists
Nursing team
Preoperative evaluation
&
Patient information and 
education
Preoperative:
•No digestive 
preparation
•Reduced fasting time
•No sedative
premedication
•Anti-nausea prophylaxis
Perioperative:
•Minimally invasive surgery
•Fluid balance
•Opioid reduction
•Normothermia
•Limited  use of drains
Postoperative:
•Balanced analgesia
(limiting opioids)
•Rapid mobilization
•Early oral refeeding
 
The patient, at the centre of this concept, is a major actor. Appropriate patient information and 
education as well as patient motivation are necessary. Indeed, the patient needs to adhere and 
take an active part in order for this approach to be successful. Age does not seem to be a limiting 
factor to FT participation.8  
Discharge from hospital and the patients return home require anticipated planning. To guarantee 
the success of a FT approach, hospital discharge criteria must be established and met as well as a 
homecare plan must be put into place. Commonly accepted discharge criteria are:  
         Lack of organ dysfunction 
         Afebrile condition 
         Simple effective analgesia 
         Normal feeding 
         Independent mobility 
         Patient consent 
The patients social network must be evaluated and support by a health aide or a visiting nurse can 
be introduced if necessary. Medical follow-up must also be organized beforehand. 
 

 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
4 
 
What are the expected benefits of “Fast track” surgery? 
FT surgery facilitates the aftermath of surgery and presents an overall benefit for patients, 
caregivers and the health care system as demonstrated in colorectal surgery.  
Overall benefits, out of which we can note: 
         Earlier rehabilitation 
         Reduced hospitalization length 
         Decreased hospital and public health costs 
         Patient satisfaction 
         Reduced postoperative complications (infections, pulmonary pathologies, ileus, ...) 
A preoccupation could be an increase in readmission rate but this hypothesis is invalidated by 
various studies.9-11 
What are the current use and benefits of 'Fast track' in gynaecological surgery? 
A recent review of the literature shows that the use of FT setting is only marginal in 
gynaecological surgery with some 30 publications identified to date in the 'Medline' and 'Ovid' 
databases as well as the 'Cochrane' library, most of which concern anaesthetic care. Indeed, no 
study has actually compared FT with conventional setting in gynaecological surgery and a fortiori 
no controlled randomized trial is found to bring a level of evidence sufficient to its wider 
implementation. The use of FT programs in gynaecological surgery however appears to be 
effective in reducing length of hospitalization in abdominal and vaginal hysterectomies as well as 
in vaginal surgery for prolapse.12-14 A small-size descriptive study was carried out by Möller and Co 
and published in 1998.12  Thirty-two patients allocated either to abdominal hysterectomy (n = 16) 
or laparoscopically assisted vaginal hysterectomy (n = 16) benefited from FT setting. The results 
showed shorter hospitalization for laparoscopically assisted vaginal hysterectomy of 1 day and 2 
days for abdominal hysterectomy. These results are encouraging in comparison to the length of 
hospitalization in classical setting which are usually doubled. Another small-size descriptive study 
including 41 patients carried out by Ottensen and Co13 and published in 2002 showed 
postoperative hospitalization of 24 hours after vaginal surgery for utero-vaginal prolapse in a fast 
track setting with no readmission occurred.  
A synthesis of the results published in different studies regarding hospitalization length in FT 
setting shows a benefit in abdominal hysterectomy by laparotomy (Figure 2). No data was found 
for hysterectomy by laparoscopic approach. 
  
 

 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
5 
 
 
Figure 2 
Hospitalization length in conventional and “Fast track” setting (in days) 
  
Conventional setting 
 
"Fast track " setting 
 
  
Abdominal hysterectomy 
  
3.815 - 5.116 
1.917- 2.618 
  
Laparoscopic hysterectomy 
  
1.818 - 3.916 
Not available 
  
 
 In gynaecologic oncology surgery, a FT setting seems to be beneficial in patients operated for 
ovarian malignancy.19-21 However, a recent Cochrane review showed that there was no evidence 
from high quality studies to support or refute the use of perioperative enhanced recovery 
programmes for gynaecological cancer patients.22  
The aspects of financial benefit for hospitals and public health have not been assessed. High 
quality studies evaluating patient satisfaction or benefits in terms of quality of life cannot be 
found. 
Conducting a randomized clinical trial in gynaecological surgery comparing FT and conventional 
setting in laparoscopic hysterectomy for benign indication, laparoscopy currently being the 
privileged way of access, is necessary to evaluate FT setting efficiency. The results of such a study 
could have major impact in perioperative care whilst demonstrating financial benefit for public 
health and patient satisfaction without changing complication and readmission rates. This is even 
more relevant in Switzerland, a country with a health care system combining fee for service and 
universal health insurance coverage, and where national health costs accounted for 11.5% of GDP 
in 2012 and are estimated at 16.7% of GDP in 2030.23 
  
  
  
 
 

 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
6 
 
Hypothesis and objectives: 
         Hypothesis: 
The concept of “Fast track” which has proven its effectiveness in colorectal surgery is applicable in 
gynaecological surgery. 
Perioperative “Fast track” setting is more efficient than conventional setting in laparoscopic 
hysterectomy for benign indication.  
         Objectives: 
The main objective of this study is to evaluate effectiveness of the “Fast track” concept in 
laparoscopic hysterectomy for benign indication in comparison to conventional setting in terms of 
cost and patient satisfaction. Earlier rehabilitation, diminution in hospitalization length and stable 
postoperative morbidity (number of thromboembolic events, number of infections, readmission 
rate) will be verified. 
Methods: 
         Design: 
Randomized control trial: the randomization in two groups will be performed by computer using 
block of different sizes (2 and 4) before patient inclusion. Sealed, opaque and numbered 
envelopes will be prepared and patients will be included consecutively.  
         Population: 
All patients in our gynaecology department, in whom an indication of total or subtotal 
laparoscopic hysterectomy for benign indication with or without adnexectomy has been 
established (including robot-assisted interventions), will be proposed this study.  
Exclusion criteria:  
Patients needing an additional surgical procedure such as a prolapse surgery or urinary 
incontinence surgery as well as malignant pathologies will not be included in the study due to 
prolonged operative time which could compromise early home return. Non-French speaking 
patients will also be excluded from the study due to the necessity of their collaboration in filling a 
logbook drawn up in French on a daily basis during their hospitalization. 


 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
7 

         Recruitment: 
During pre-hospitalisation visit where surgical indications are established, eligible patients will 
meet a research nurse who will explain the study giving patients oral and written information. If 
the patient agrees to participate in the study, she will be included randomly in one of the two 
groups after having signed a consent form. She will immediately be informed of her allocation to 
the “Fast track” or the control group in order to best prepare her personal perioperative planning. 
To increase the number of patients recruited, patients that meet the criteria of the study but who 
were not informed during the pre-hospitalisation visit will be contacted by a research nurse after 
the weekly colloquium of surgical indications, colloquium where all surgical indications of the 
department of gynaecology of the HUG are confirmed. 
          Intervention: 
Two types of perioperative settings will be compared:  
o Group 1: “Fast track” protocol 
o Group 2: conventional setting 
  
1) “FAST TRACK” protocol 
Preoperative evaluation and information: 
o Patient information of the study during the pre-hospitalisation visit and patient consent to 
participate in the study prior to hospitalization. 
o Patient general health state optimization proposal prior to hospitalization: 
         Smoking cessation, if necessary (specialized consultation) 
         Weight loss, if necessary (nutrition consultation) 
        Patient autonomy and social environment evaluation (home care proposal if 
necessary) 
 
 
 

 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
8 
 
 Preoperative strategy: 
o Hospitalization on surgery day 
o No prolonged fasting (solids stopped 6 hours before surgery and liquids encouraged up to 
two hours before surgery) 
 
Perioperative strategy: 
o Anti-infectious prophylaxis: Cefazolin 2g IV  
o Pain control based on limited systemic opioid therapy use  
o Anti-nausea prophylaxis: 4g Dexamethasone preoperative + 4mg Ondansetron 
postoperative 
o Fluid balance 
o Anaesthesia via IV propofol / remifentanyl 
o Bladder catheter removal postoperative 
 
 Postoperative strategy: 
o Pain control using balanced analgesia 
o Gum chewing 
o Antithrombotic prophylaxis by low-molecular-weight heparin (40mg/60mg, depending on 
patient weight, 6 hours post-op during entire hospital stay)  
o Early oral refeeding (as of 4 h postoperative)  
o Rapid mobilization (as of 4 h postoperative) 
o Venflon removal 6 hours post-op 
o Standard criteria for hospital discharge the day after surgery, checked by a physician: 
 Lack of organ dysfunction (evaluated by physical examination) 
 Afebrile condition 
 Simple effective analgesia 
 Normal feeding 
 Independent mobility 
 Patient consent 
o Planned outpatient follow-up: stitches/ skin staples removal on day 7, postoperative check-
up on day 30 
o Home care if needed 
 The protocol will have to be well-known by surgeons, anaesthetists and the nursing team. 

 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
9 
  
2) «Conventional setting» protocol 
Pre-hospital assessment  
o Surgical indication determination and surgical procedure explanation 
Preoperative strategy: 
o Hospitalization on surgery day  
o Fasting as of midnight prior to the day of surgery 
Perioperative strategy: 
Treatments according to the surgeons and the anaesthesiologists practice: 
o Anti-infectious prophylaxis: Cefazolin 2g IV  
o Balanced anaesthesia via halogens gases 
Postoperative strategy: 
o Mobilization depending on patient’s general condition, on the evening of the surgery, at 
minimum 6 hours post operation 
o Antithrombotic prophylaxis by low-molecular-weight heparin (40mg/60mg, depending on 
patient weight, 6 hours post-op during entire hospital stay) 
o Same day refeeding, depending on the patient’s general condition and according to her 
desire, proposed on the evening of the surgery at minimum 6 hours post operation  
o Bladder catheter and Venflon removal on day 1 
 
o Standard criteria for hospital discharge the day after surgery, checked by a physician: 
 Lack of organ dysfunction (evaluated by physical examination) 
 Afebrile condition 
 Simple effective analgesia 
 Normal feeding 
 Independent mobility 
 Patient consent 
o Planned outpatient follow-up: stitches/ skin staples removal on day 7, postoperative check-
up on day 30 
o Home care if needed


 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
10 

  
 
Issues: 
o Main: 
 Total costs: hospitalization costs and costs during the first month after surgery 
(ambulatory, home care and family/friends loss of earnings) (1) 
o 
Secondary: 
 Patient satisfaction (2) 
 Earlier rehabilitation (3) : pain comparison via pain scale (0-10) and 
resumption of normal bowel function via day of first stools and gas post-op 
 Morbidity during the first post-operation month (4): 
-readmission rate 
-number of infections 
-number of thromboembolic events  
In order to measure the impact of the intervention on our practice, the length of hospitalization 
“Fast track” and conventional setting will be compared. 
          Instruments: 
1)  Costs of the two types of setting (“Fast track” and classic) will be compared taking into 
account hospitalization and ambulatory costs which will be obtained via the patient EDS 
number as discussed with the medico-information department (Mrs. Claudine Bréant). In 
addition, home care will be accounted for via invoices and family/friends loss of earnings 
will be calculated based on the number of absent working days. With Switzerland’s 
median wage of CHF 6118 per month in 2012 and approximately 21 working days per 
month, we can estimate a median wage of CHF 291 per working day.24 
2)  Patients satisfaction in both groups will be evaluated via a satisfaction questionnaire on 
their day of return home and at their follow-up visit one month after surgery.  
3)  Patients will be given a logbook questioning them on their pain awareness, their digestion 
and their mobilisation during their hospital stay.  
4) Morbidity during the first month post-operation (i.e. readmission rate, number of 
infections and number of thromboembolic events) will be evaluated via the medical staff 
case report form. 
 
 

 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
11 
 
A medical staff case report form containing their detailed clinical pathway will be used to 
verify patient’s adhesion rate at each stage of the protocol. 
A care map for each group will be used by the medical staff as a synopsis of the clinical 
pathway and will have to be signed by each medical intervener (nurse, gynaecologist and 
anaesthetist). 
         Sample size 
Sample size is calculated based on the difference of means for total costs in between the two 
groups including hospitalization costs and costs during the first month after surgery (ambulatory, 
home care and social environments loss of earnings). The null hypothesis tested will be that costs 
are identical in the two groups.  
In order to obtain a power of 90% for type I error with a significance threshold at 0.05 in a two-
tailed distribution and in order to highlight a difference equal to 0.5 standard deviations which is 
clinically relevant, the study will need to include 170 patients (n1 = 85; n2 = 85). Assuming an 
average cost of CHF 10'000 per hysterectomy for benign indication (CHF 12’809 in 2013, 
information given by Dr Peter Rohner, financial medical controller), it will be possible to highlight 
a statistically significant difference of CHF 1400 per surgery corresponding to 10% of the total 
amount which would be considered as clinically relevant.  
         Type of analysis 
The two groups will be compared in terms of their background characteristics which could 
influence study outcome. Factors such as age, BMI, hypertension, diabetes, and smoking will be 
taken into consideration. Patients adhesion rate at each stage of the protocol in the 'Fast track' 
group will also be evaluated. Special attention will be given to hospitalization length in the two 
groups. 
Data will be analysed by the intention-to-treat approach. Patients will remain in the group to 
which they were initially allocated to at the beginning of the study. 
Total average costs between the two groups will be compared using a T-Test with a 95% 
confidence interval. In the same way, global and per intervention patient satisfaction will be 
analysed with a T-Test even though they do not follow a normal distribution (right-tailed 
distribution). A second total average cost analysis will also be performed excluding patients who 
presented major perioperative complications requiring for instance intensive care unit which may 
influence study outcome with no direct relation to “Fast track” protocol. 
 

 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
12 
 
Readmission rate, number of infections and number of thromboembolic events will also be 
compared between the two groups in terms of risk differences with a confidence interval of 95%. 
If these complications are sufficiently numerous, a Fisher's test will be used for comparison.  
 
Ethics: 
The study protocol will be submitted to the ethics committee of the Geneva University hospital 
(HUG). If approval is given by the ethics committee, all patients with a surgical indication of 
laparoscopic hysterectomy for benign indication in the gynaecology department of the HUG will 
be proposed to participate in this study. Eligible patients will receive oral and written information 
by a research nurse. Study participation will be voluntary and participants will be free to withdraw 
from the study at any time. Written consent will be given before inclusion in the study.  
To ensure patient confidentiality, once a patient accepts to participate in the study she will 
receive a study number on a first-come, first-served basis. For instance Mrs Dupont, 58th 
participant will be known under patient 58 irrelevant of whether she has been attributed to the 
protocol FT or conventional. This number will be written on the patient information and consent 
form, the medical staff case report, the care map and the patient’s log-book. The document 
containing the name of the patient paired with her study number (la main courante) will be kept 
under lock at the clinical research unit of the gynaecology department. Only the investigators and 
the research nurses will have access to this document.  
The patient information and consent form, the medical staff case report, the care map and the 
patient’s log-book will also be kept at the clinical research unit of the gynaecology department 
where only the investigators and the research nurses will have access. 
Study participation presents no particular risk for patients since the “Fast track” concept has 
already demonstrated efficiency in colorectal surgery with no morbidity increase. Moreover, the 
various stages of the “Fast track” protocol are already commonly applied on a case-by-case basis 
in our current conventional setting. The choice to exclude from the study patients needing an 
additional surgical procedure such as a prolapse surgery or urinary incontinence surgery as well as 
malignant pathologies is justified by the fact that operating time is prolonged which could 
compromise homogeneity of the sample. Non-French speaking patients will also be excluded from 
the study due to the necessity of their collaboration in filling a logbook drawn up in French on a 
daily basis during their hospitalization. 
A liability insurance policy will be issued in the name of the HUG by Me Marescotti (legal advisor) 
as soon as approval has been given by the ethics committee of the Geneva University hospital 
(HUG). 
 

 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
13 
 
Logistics: 
         Calendar  
With an estimated patient eligibility of 140 laparoscopic hysterectomies for benign indication 
per year in the department of genecology of the HUG and a recruitment rate of one patient 
on two. 
 
1st year 
2014 
2nd year 
2015 
3rd year 
2016 
4th year 
2017 
5th year 
2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Trimesters 
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
General organization 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Document preparation 
(logbooks and patient 
satisfaction questionnaire, ethics 
committee submission & 
agreement and fund raising) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Database preparation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient recruitment and data 
collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Additional data entry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Results and manuscript 
drafting 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Publication 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
         Collaboration between surgeons, anaesthetists and caregivers 
All interveners of the gynaecology department will be informed orally by the main investigator 
during an information session and by written. A copy of the study protocol will be sent by e-mail. 
Anaesthetists will also be informed orally by the main investigator and a representative who 
already has experience in the “Fast track” concept will be officially appointed. A copy of the study 
protocol will be sent by e-mail. 
Finally, the nursing team will also be informed in the same way and a representative will also be 
appointed.  
 
 

 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
14 
 
         Funding: 
A funding application will be made to the medical direction of the HUG as part of a Research and 
development project with the purpose to gather the necessary budget: 
 
Two research nurses at 50% for two years and at 40% for the last 6 
months (total of 200'000 CHF) 
Project to be submitted to Fondation privée des HUG 
 
Computing resources, office equipment and premises will be made 
available by the HUG.  

 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
15 
50% 
10% 
170 
Patient general health state 
optimization proposal + family 
meeting if necessary 
 Flowchart: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
340 HL estimated on 2,5 years 
Exclusion (170): 
- Non eligible (25%) 
- Refusal (25%) 
Randomized patients (N=170) 
« Fast Track » protocol (N=85) 
Conventional setting protocol (N=85) 
Exclusion (20): 
- Non eligible 
- Withdrawal 
Additional patient entry (20) 
Perioperative 
Postoperative 
- Hospitalization on surgery day  
- No prolonged fasting / encourage drinking up to 2 
hours prior to surgery 
- Anti-infectious prophylaxis: Cefazolin 2g IV 
- Pain control based on limited systemic opioid use  
- Anti-nausea prophylaxis (4mg Dexamethasone 
preoperative and 4mg Ondansetron postoperative) 
- Fluid balance 
- Anaesthesia via IV proprofol/remi-fentanyl 
- Bladder catheter removal immediate post-op 
- Pain control using balanced analgesia 
- Early oral refeeding (as of 4 h postoperative)  
- Rapid mobilization (as of 4 h postoperative) 
- Gum chewing 
- Antithrombotic prophylaxis by low-molecular-
weight heparin 6h post-op 
- Venflon removal 6h post-op 
Criteria for discharge for both groups: 
- Lack of organ dysfunction 
- Afebrile condition 
- Simple effective analgesia 
- Normal feeding 
- Independent mobility 
- Patient consent 
Home care if needed 
Satisfaction enquiry on day of discharge 
Planned outpatient follow-up:  
- stitches/ skin staple removal + check up on day 7  
- postoperative check-up + satisfaction enquiry on day 
30   
- Hospitalization on surgery day  
- Fasting as of midnight prior to the day of surgery 
 
Treatments according to the surgeons and the 
anaesthesiologists practice: 
- Anti-infectious prophylaxis: Cefazolin 2g IV 
- Balanced anaesthesia via halogens gases 
 
- Antithrombotic prophylaxis by low-molecular-
weight heparin 6h post-op  
- Same day refeeding according to patient’s desire 
(min 6 hours post operation) 
- Same day mobilization according to patient’s 
general state (min 6 hours post-operation) 
- Bladder catheter and Venflon removal on day 1 
Preoperative 
Planned outpatient follow-up:  
- stitches/ skin staple removal + check up on day 7  
- postoperative check-up + satisfaction enquiry on day 
30   

 
« Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
16 
 
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 « Fast track » surgery on patient undergoing minimally invasive 
 gynaecologic procedure : a randomized clinical trial. V2.0 – 2015.09.29 
Etude CCER n° 15-103 : Fast Track _V.2.0-2015.09.29 
 
 
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