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Benefit of Rehabilitation Program in Colorectal Surgery (REHAB)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rehabilitation program
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring Rehabilitation program, Fast track surgery, Laparoscopic colorectal resection, Colorectal cancer, Morbidity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de chirurgie Colorectale / Hôpital Beaujon

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

1: Standard surgery + Standard care

2: Laparoscopy + Rehabilitation program

Arm Description

standard surgery and Standard care after surgery

Laparoscopic colorectal surgery with rehabilitation program

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Mortality according to DINDO CLAVIEN classification
Mortality according to DINDO CLAVIEN classification (grade V)
Hospital stay and readmissions
Initial hospital stay and possible unscheduled readmissions
Intravenous perfusion stay
Global (SF36) quality of life
Global (SF36) and specific (GIQLI) quality of life 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
Duration of laxation (gas and stool)

Full Information

First Posted
April 20, 2012
Last Updated
August 18, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01609361
Brief Title
Benefit of Rehabilitation Program in Colorectal Surgery
Acronym
REHAB
Official Title
Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Rehabilitation program, Fast track surgery, Laparoscopic colorectal resection, Colorectal cancer, Morbidity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Standard surgery + Standard care
Arm Type
No Intervention
Arm Description
standard surgery and Standard care after surgery
Arm Title
2: Laparoscopy + Rehabilitation program
Arm Type
Other
Arm Description
Laparoscopic colorectal surgery with rehabilitation program
Intervention Type
Other
Intervention Name(s)
Rehabilitation program
Intervention Description
Rehabilitation program including specific anesthetic drugs, post operative fast track recovery (early diet, mobilisation, antalgics)
Primary Outcome Measure Information:
Title
Post operative morbidity at 30 days according to DINDO CLAVIEN classification
Description
Post operative morbidity at 30 days according to DINDO CLAVIEN classification (grade I to IV)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mortality according to DINDO CLAVIEN classification
Description
Mortality according to DINDO CLAVIEN classification (grade V)
Time Frame
up to 30 days
Title
Hospital stay and readmissions
Description
Initial hospital stay and possible unscheduled readmissions
Time Frame
up to first month
Title
Intravenous perfusion stay
Time Frame
participants will be followed until the end of hospitalization an expected average of 2 weeks
Title
Global (SF36) quality of life
Description
Global (SF36) and specific (GIQLI) quality of life Preoperative and at 1, 3, 6 months
Time Frame
Preoperative and at 1, 3, 6 months
Title
Specific (GIQLI) quality of life
Description
Global (SF36) and specific (GIQLI) quality of life Preoperative and at 1, 3, 6 months
Time Frame
Preoperative and at 1, 3, 6 months
Title
Duration of laxation (gas and stool)
Time Frame
up to hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Service de chirurgie Colorectale / Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France

12. IPD Sharing Statement

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Benefit of Rehabilitation Program in Colorectal Surgery

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