Benefit of Rehabilitation Program in Colorectal Surgery

Overview

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

Full Title of Study: “Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Investigator)
  • Study Primary Completion Date: February 2016

Detailed Description

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

Interventions

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

Arms, Groups and Cohorts

  • No Intervention: 1: Standard surgery + Standard care
    • standard surgery and Standard care after surgery
  • Other: 2: Laparoscopy + Rehabilitation program
    • Laparoscopic colorectal surgery with rehabilitation program

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor

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