Benefit of Rehabilitation Program in Colorectal Surgery (REHAB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01609361
First received: April 20, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Colorectal Cancer
Other: Rehabilitation program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Post operative morbidity at 30 days according to DINDO CLAVIEN classification [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Post operative morbidity at 30 days according to DINDO CLAVIEN classification (grade I to IV)


Secondary Outcome Measures:
  • Mortality according to DINDO CLAVIEN classification [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]
    Mortality according to DINDO CLAVIEN classification (grade V)

  • Hospital stay and readmissions [ Time Frame: up to first month ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Global (SF36) quality of life [ Time Frame: Preoperative and at 1, 3, 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1: Standard surgery + Standard care
standard surgery and Standard care after surgery
2: Laparoscopy + Rehabilitation program
Laparoscopic colorectal surgery with rehabilitation program
Other: Rehabilitation program
Rehabilitation program including specific anesthetic drugs, post operative fast track recovery (early diet, mobilisation, antalgics)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609361

Contacts
Contact: Yves PANIS, MD,PhD 33 1 40 87 45 47 yves.panis@bjn.aphp.fr
Contact: Léon MAGGIORI, MD 33 1.40.87.55.67 leon.maggiori@bjn.aphp.fr

Locations
France
Service de chirurgie Colorectale / Hôpital Beaujon Recruiting
Clichy, France, 92110
Contact: Yves PANIS, MD,PhD    33 (1) 40 87 45 47    yves.panis@bjn.aphp.fr   
Contact: Léon MAGGIORI, MD    33 (1) 40.87.55.67    leon.maggiori@bjn.aphp.fr   
Principal Investigator: Yves PANIS, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01609361     History of Changes
Other Study ID Numbers: P111006, IDRCB
Study First Received: April 20, 2012
Last Updated: October 23, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Rehabilitation program
Fast track surgery
Laparoscopic colorectal resection
Colorectal cancer
Morbidity

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 21, 2014