Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery

Assistance Publique - Hôpitaux de Paris1 site in 1 country270 target enrollmentNovember 2012

ConditionsColorectal Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Cancer
Sponsor: Assistance Publique - Hôpitaux de Paris
Enrollment: 270
Locations: 1
Primary Endpoint: Post operative morbidity at 30 days according to DINDO CLAVIEN classification
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

July 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Assistance Publique - Hôpitaux de Paris

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

Mortality according to DINDO CLAVIEN classification(up to 30 days)
Hospital stay and readmissions(up to first month)
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)
Duration of laxation (gas and stool)(up to hospital discharge)
Global (SF36) quality of life(Preoperative and at 1, 3, 6 months)