Benefit of Rehabilitation Program in Colorectal Surgery

Colorectal Cancer Clinical Trial

— REHAB  

Official title:

Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609361
• Other study ID #: P111006
• Secondary ID: IDRCB
• Status: Completed
• Phase: N/A
• First received: April 20, 2012
• Last updated: August 18, 2016
• Start date: November 2012
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: July 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Rehabilitation program
Rehabilitation program including specific anesthetic drugs, post operative fast track recovery (early diet, mobilisation, antalgics)

Locations

Country	Name	City	State
France	Service de chirurgie Colorectale / Hôpital Beaujon	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Mortality according to DINDO CLAVIEN classification	Mortality according to DINDO CLAVIEN classification (grade V)	up to 30 days	Yes
Secondary	Hospital stay and readmissions	Initial hospital stay and possible unscheduled readmissions	up to first month	Yes
Secondary	Intravenous perfusion stay		participants will be followed until the end of hospitalization an expected average of 2 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Duration of laxation (gas and stool)		up to hospital discharge	No