Rectal Cancer Surgery Without Mechanical Bowel Preparation (PREPACOL)
Primary Purpose
Patients With Rectal Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bowel preparation
no preparation bowel
Sponsored by
About this trial
This is an interventional treatment trial for Patients With Rectal Cancer focused on measuring Rectal cancer, Sphincter preservation, Mechanical bowel preparation, Post operative morbidity, Anastomotic leakage
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- patient with rectal cancer without any metastasesRectal excision with sphincter preservation with colorectal or coloanal anastomosis (with or without temporary ileostomy)
Exclusion Criteria:
- Stage IV disease
- Comorbidity with post operative infectious risk corticoids,immunodeficiency, Crohn's disease, ulcerative colitis ...)
- Abdominoperineal resection
- Emergency surgery
Sites / Locations
- CHU
- Hopital Saint André
- Hopital Ambroise Paré
- CHU
- Hôpital Beaujon
- Hopital Nord
- Institut Paoli Calmette
- CRLC Val d'Aurelle
- Hopital Cochin
- CHU Purpan
- CHRU Trousseau
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Bowel preparation
without bowel preparation
Outcomes
Primary Outcome Measures
Overall morbidity including infectious and non infectious complications
Secondary Outcome Measures
- peri operative mortality - non infectious morbidity - anastomotic leakage - hospital stay - per operative evaluation of bowel preparation - clinical evaluation of bowel preparation
Evaluate the postoperative complications classified according to the DINDO classification.
Full Information
NCT ID
NCT00554892
First Posted
November 6, 2007
Last Updated
June 29, 2010
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00554892
Brief Title
Rectal Cancer Surgery Without Mechanical Bowel Preparation
Acronym
PREPACOL
Official Title
ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this controlled multicentric study is to assess rectal cancer surgery with sphincter preservation without pre operative mechanical bowel preparation
Detailed Description
Preoperative mechanical bowel preparation (MBP) (i.e. including oral laxatives, retrograde enemas and/or oral diet before surgery) is the standard practice in colorectal surgery. The importance of MBP in preventing anastomotic leakage and infectious morbidity after elective colorectal surgery has been a dogma among surgeons for many years. The main reason is the belief that postoperative complications is related to septic bowel content. However, there is a paucity of scientific evidence demonstrating the efficacy of this practice in reducing morbidity. Moreover, potential disadvantages of MBP include the requirement for a longer preoperative duration of admission before surgery, its time consuming nature, being expensive and unpleasant for the patient and expose the early population to the particular risk of fluid and electrolyte imbalance .At least eight randomized clinical trials and two meta-analyses failed to show any superiority of MBP in colorectal surgery. On the contrary, they demonstrated that preparation might lead to an increased rate of septic complications. Such initial dates lead surgeons to re-evaluate their current clinical practice in colonic surgery. But to dates, these findings cannot finally be applied to rectal surgery because of insufficient dates. To date, no study about MBP was specifically devoted to rectal surgery. Moreover, it is currently admitted that the risk of septic complications following rectal resection, as a result of the well-known risk factors, is higher than after colonic preparation. It is the reason why most of the colorectal surgeons consider that a no preparation regimen in rectal cancer surgery could represent an additive risk factor for postoperative morbidity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Rectal Cancer
Keywords
Rectal cancer, Sphincter preservation, Mechanical bowel preparation, Post operative morbidity, Anastomotic leakage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Bowel preparation
Arm Title
2
Arm Type
Experimental
Arm Description
without bowel preparation
Intervention Type
Procedure
Intervention Name(s)
bowel preparation
Intervention Description
oral laxatives, retrograde enemas
Intervention Type
Procedure
Intervention Name(s)
no preparation bowel
Intervention Description
no preparation bowel
Primary Outcome Measure Information:
Title
Overall morbidity including infectious and non infectious complications
Time Frame
peri operative
Secondary Outcome Measure Information:
Title
- peri operative mortality - non infectious morbidity - anastomotic leakage - hospital stay - per operative evaluation of bowel preparation - clinical evaluation of bowel preparation
Time Frame
30 days, 6 months
Title
Evaluate the postoperative complications classified according to the DINDO classification.
Time Frame
during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
patient with rectal cancer without any metastasesRectal excision with sphincter preservation with colorectal or coloanal anastomosis (with or without temporary ileostomy)
Exclusion Criteria:
Stage IV disease
Comorbidity with post operative infectious risk corticoids,immunodeficiency, Crohn's disease, ulcerative colitis ...)
Abdominoperineal resection
Emergency surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PANIS Yves, Pr
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Hopital Saint André
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hopital Ambroise Paré
City
Boulognes Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
CHU
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital Nord
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
CRLC Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHRU Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
21037443
Citation
Bretagnol F, Panis Y, Rullier E, Rouanet P, Berdah S, Dousset B, Portier G, Benoist S, Chipponi J, Vicaut E; French Research Group of Rectal Cancer Surgery (GRECCAR). Rectal cancer surgery with or without bowel preparation: The French GRECCAR III multicenter single-blinded randomized trial. Ann Surg. 2010 Nov;252(5):863-8. doi: 10.1097/SLA.0b013e3181fd8ea9.
Results Reference
derived
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Rectal Cancer Surgery Without Mechanical Bowel Preparation
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