Benefit of Rehabilitation Program in Colorectal Surgery (REHAB)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: Rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT01609361

P111006

IDRCB (Other Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 2 patient groups

1: Standard surgery + Standard care

No Intervention group

Description:

standard surgery and Standard care after surgery

2: Laparoscopy + Rehabilitation program

Other group

Description:

Laparoscopic colorectal surgery with rehabilitation program

Treatment:

Other: Rehabilitation program