Benefit of Rehabilitation Program in Colorectal Surgery

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Rehabilitation program

• Registration Number: NCT01609361
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-06-01
• Study Start: 2012-11
• Primary Completion: 2016-02
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-18
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2: Laparoscopy + Rehabilitation program	Rehabilitation program	Laparoscopic colorectal surgery with rehabilitation program

Primary Outcome Measures

Name	Time	Method
Post operative morbidity at 30 days according to DINDO CLAVIEN classification	30 days	Post operative morbidity at 30 days according to DINDO CLAVIEN classification (grade I to IV)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service de chirurgie Colorectale / Hôpital Beaujon; 🇫🇷 Clichy, France