Clinical trial NCT03353311: ERAS Lazio Network Clinical Registry
Official title: ERAS Lazio Network Clinical Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Diverticulum, Colon
Keywords: ERAS
Fast-track
colorectal surgery
immuno-nutrition
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera "Sant'Andrea"
name: Policlinico Casilino ASL RMB
name: San Giovanni Addolorata Hospital
name: Campus Bio-Medico University
name: Ospedale San Paolo Civitavecchia
name: Ospedale Cristo Re - Roma
name: S.Eugenio Hospital
First posted: 2017-11-27
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Open or laparoscopic colorectal surgical resection for a benign/malignant disease independently from patients age or sex

Brief summary: Enhanced recovery after surgery (ERAS) protocols are programs aiming to implement patients recovery following surgical procedures developed about 25 years ago. ERAS protocols are based on a multi-disciplinary approach encompassing surgery, anesthesiology, nutrition and nursing; each specialty has to fulfill a number of items which have been demonstrated to reduce morbidity rates, hospital stay and to implement functional recovery comparing standard approach. Accordingly, ERAS society developed a Guidelines for a number of procedures, including colorectal.

The aim of this study is to evaluate the adherence over the last years to these protocols in eight Department of Surgery in Rome in a series of colorectal cancer patients.

Secondary aims are to investigate the correlation of the items adherence with surgical outcome and to establish a network of hospitals aiming to promote ERAS approach on a regional base.

Detailed description: Background. The acronym ERAS (Enhanced Recovery After Surgery) refers to a patient-centered, evidence-based multi-disciplinary protocol designed to implement perioperative operation, reduce surgical trauma, and facilitate recovery of physiological functions aiming to an early hospital discharge.

Usually ERAS protocols give a continuum of care starting at home (pre-hospital/pre-admission phase) to continue in followed by the pre-/ intra-/ and post-operative phases.

ERAS includes a wide range of disciplines and specialists, which focus on the needs of the patient in order to improve support by facilitating his return home.

The first author to introduce the fast-track term in rectal surgery was Prof. Henrik Kehlet in the mid-1990s, proposing a multi-modal rehabilitation program aimed to reduce post-surgical stress response, morbidity, mortality and postoperative hospitalization. Since then, a number of studies were conducted leading to the first ERAS protocol; since then, these protocols were reviewed on a regular basis, the last time in 2017 and included in the guidelines by the ERAS society (http://www.erassociety.org).

Currently, it is widely demonstrated that, comparing to a traditional approach, ERAS is associated with a significant reduction in morbidity, days of hospitalization, mortality, implementing early postoperative recovery with a consequent reduction of the costs, without compromising patient safety.

In particular, ERAS for colorectal surgery, includes 24 demonstrated multi-disciplinary.

Aims. the investigators aim to evaluate the adherence to the individual items and the short-term outcomes (postoperative hospitalization, complication rates within 30 days of intervention, re-intervention) in a consecutive series of patients undergoing colorectal resection, in eight centers in the Lazio region, treated according to the ERAS protocol.

Secondary aims are to investigate the correlation of the items adherence with surgical outcome and to establish a network of hospitals aiming to promote ERAS approach on a regional base.

Design. This is a no-profit, spontaneous, observational, non-intervention Audit collecting data in eight surgical Departments based in Lazio region, since September 2014 to October 2017. Each participating center will be depositary of its own data.

Participating Centers.

1. UOC General Surgery 1, Fondazione Policlinico Universitario "A. Gemelli ", Rome (Coordinator) -
2. Department of Surgery, S. Eugenio Hospital, Rome
3. UOD Week-Day Surgery, St. Andrea Hospital, Rome
4. UOC General Surgery, Polyclinic University Bio-Medical Campus, Rome
5. UO General and Urgent Surgery, Policlinico Casilino Hospital, Rome
6. UOC Surgery, San Paolo Hospital, Civitavechia (RM)
7. UOC General Surgery, Cristo Re Hospital, Rome
8. UOSD Robotic Surgery for General Surgery, San Giovanni-Addolorata Hospital, Rome

Data Collection. Each center will collect the data in a homogeneous Database. The data will be collected in anonymous form and will be aimed at the definition of:

1. Duration of postoperative stay
2. Short-term morbidity rate (within 30 days) according to Clavien-Dindo classification
3. Re-intervention rate (within 30 days)
4. Hospital readmission (within 30 days)

f. Adherence rate to items of the series All data will be treated sensibly; each patient will be recorded with a sequential center-specific code. For all new patients and for patients seen in follow-up visits, the specific informed consent of the study will be compiled.

Statistical analysis. Categorical variables will be presented as rate and percentages, the continuous variables as mean, median, and standard deviation.

A logistic regression will also be performed, computing items as co-variates, with the end-point of post-operative morbidity and hospital stay.

Sample Size Calculation: 1000 patients, calculated on the basis of the annual case of each participating center.

For the conduct and management of this observational study no additional cost will be charged on NHS funds.

Eligibility criteria: Inclusion Criteria:

* Elective colorectal surgical resection
* Open and Laparoscopic Suregry
* Benign/malignant disease
* independently from age, sex,

Exclusion Criteria:

Emergency colorectal resections

Primary outcomes:
measure: Adherance to ERAS protocol
timeFrame: 36 months
Secondary outcomes:
measure: Number of items of the ERAS protol correlated wih adverse events as described by the Clavien Dindo Classification and with a longer hospital stay
timeFrame: 36 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Unversitario Agostino Gemelli
Study officials:
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