Benefit of Rehabilitation Program in Colorectal Surgery (REHAB)

Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery

Rehabilitation program improves operative results following conventional open colorectal surgery. Very few data are available on such program in laparoscopic colorectal surgery.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Rehabilitation program

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clichy, France, 92110
    • Service de chirurgie Colorectale / Hôpital Beaujon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 20, 2012
• First Submitted That Met QC Criteria: May 29, 2012
• First Posted (Estimate): June 1, 2012

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: August 18, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Colorectal cancer; Morbidity; Rehabilitation program; Fast track surgery; Laparoscopic colorectal resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: P111006; IDRCB (Other Identifier: 2025-A01568-41)