Benefit of Rehabilitation Program in Colorectal Surgery (REHAB)

This study is not yet open for participant recruitment.

Verified September 2012 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: September 3, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 20, 2012

Last Updated Date

September 3, 2012

Start Date ^ICMJE

October 2012

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Post operative morbidity at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Post operative morbidity at 30 days

Change History

Complete list of historical versions of study NCT01609361 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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
Intraveinous 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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Benefit of Rehabilitation Program in Colorectal Surgery

Official Title ^ICMJE

Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery

Brief Summary

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

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Colorectal Cancer

Intervention ^ICMJE

Other: Rehabilitation program

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

270

Estimated Completion Date

November 2014

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

age > 18 years old
colorectal cancer
inform and consent form signed
patient has valid health insurance/coverage

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
Pregancy or maternal breastfeeding

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yves PANIS, MD,PhD	33 1 40 87 45 47	yves.panis@bjn.aphp.fr
Contact: Frédéric BRETAGNOL, MD-PHD	33 1 40 87 45 47	frederic.bretagnol@bjn.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01609361

Other Study ID Numbers ^ICMJE

P111006, IDRCB

Has Data Monitoring Committee

Responsible Party

Assistance Publique - Hôpitaux de Paris

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

September 2012

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

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