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

April 20, 2012
October 23, 2013
November 2012
June 2014   (final data collection date for primary outcome measure)
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)
Post operative morbidity at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Post operative morbidity at 30 days
Complete list of historical versions of study NCT01609361 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Mortality [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]
  • Hospital stay and readmissions [ Time Frame: up to first month ] [ Designated as safety issue: Yes ]
    Initial hospital stay and possible unscheduled readmissions
  • Intraveinous perfusion stay [ Time Frame: until the end of hospitalization ] [ 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
Not Provided
Not Provided
 
Benefit of Rehabilitation Program in Colorectal Surgery
Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery

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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Colorectal Cancer
Other: Rehabilitation program
Rehabilitation program including specific anesthetic drugs, post operative fast track recovery (early diet, mobilisation, antalgics)
  • No Intervention: 1: Standard surgery + Standard care
    standard surgery and Standard care after surgery
  • 2: Laparoscopy + Rehabilitation program
    Laparoscopic colorectal surgery with rehabilitation program
    Intervention: Other: Rehabilitation program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
December 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
France
 
NCT01609361
P111006, IDRCB
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP