Benefit of Rehabilitation Program in Colorectal Surgery (REHAB)

August 18, 2016 updated by: Assistance Publique - Hôpitaux de Paris

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P111006
  • IDRCB (Other Identifier: 2025-A02589-40)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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