Benefit of Rehabilitation Program in Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
Rehabilitation program improves operative results following conventional open colorectal surgery. Very few data are available on such program in laparoscopic colorectal surgery.

Detailed Description
-----------------
The aim is to assess rehabilitation program in laparoscopic colorectal surgery in terms of 30 days peri operative complications

Official Title
-----------------
Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: Rehabilitation program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years old Colorectal cancer Inform and consent form signed Patient has valid health insurance/coverage Functional capacity ≥ 4 METs (metabolic equivalents) (up 1 floor without stopping, walking down the street 5-7km / h, major domestic activities) Patients with laparoscopic resection for colorectal cancer including abdominoperineal resection Inclusion Criteria (arm : Laparoscopy + Rehabilitation program): Tobacco and alcohol weaning Exclusion Criteria: MBI < 18kg/m2 severe malnutrition Metastatic colorectal cancer Buzby Index <83 Combined surgery (hepatic resection or segmental resection of small intestine) Urgent surgery Pregnancy or maternal breastfeeding Body mass index (BMI)> 30 kg/m2 Abdominoperineal resection Subtotal colectomy Total proctocolectomy Cons to Naropin Xylocaine, droperidol, ketamine Patient with a history of peptic ulcer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1: Standard surgery + Standard care<br>standard surgery and Standard care after surgery | |
| Other: 2: Laparoscopy + Rehabilitation program<br>Laparoscopic colorectal surgery with rehabilitation program | Other: Rehabilitation program<br>* Rehabilitation program including specific anesthetic drugs, post operative fast track recovery (early diet, mobilisation, antalgics)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative morbidity at 30 days according to DINDO CLAVIEN classification | Post operative morbidity at 30 days according to DINDO CLAVIEN classification (grade I to IV) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality according to DINDO CLAVIEN classification | Mortality according to DINDO CLAVIEN classification (grade V) | up to 30 days | 
| Hospital stay and readmissions | Initial hospital stay and possible unscheduled readmissions | up to first month | 
| Intravenous perfusion stay |  | participants will be followed until the end of hospitalization an expected average of 2 weeks | 
| Global (SF36) quality of life | Global (SF36) and specific (GIQLI) quality of life Preoperative and at 1, 3, 6 months | Preoperative and at 1, 3, 6 months | 
| Specific (GIQLI) quality of life | Global (SF36) and specific (GIQLI) quality of life Preoperative and at 1, 3, 6 months | Preoperative and at 1, 3, 6 months | 
| Duration of laxation (gas and stool) |  | up to hospital discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation program, Fast track surgery, Laparoscopic colorectal resection, Colorectal cancer, Morbidity