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Rectal Cancer Surgery Without Mechanical Bowel Preparation (PREPACOL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00554892
First Posted: November 7, 2007
Last Update Posted: June 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose
The aim of this controlled multicentric study is to assess rectal cancer surgery with sphincter preservation without pre operative mechanical bowel preparation

Condition Intervention
Patients With Rectal Cancer Procedure: bowel preparation Procedure: no preparation bowel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation

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

Primary Outcome Measures:
  • Overall morbidity including infectious and non infectious complications [ Time Frame: peri operative ]

Secondary Outcome Measures:
  • - 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 ]
  • Evaluate the postoperative complications classified according to the DINDO classification. [ Time Frame: during the study ]

Enrollment: 186
Study Start Date: September 2007
Study Completion Date: August 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Bowel preparation
Procedure: bowel preparation
oral laxatives, retrograde enemas
Experimental: 2
without bowel preparation
Procedure: no preparation bowel
no preparation bowel

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554892


Locations
France
CHU
Angers, France, 49000
Hopital Saint André
Bordeaux, France, 33075
Hopital Ambroise Paré
Boulognes Billancourt, France, 92100
CHU
Clermont-Ferrand, France, 63000
Hôpital Beaujon
Clichy, France, 92110
Hopital Nord
Marseille, France, 13000
Institut Paoli Calmette
Marseille, France, 13273
CRLC Val d'Aurelle
Montpellier, France, 34298
Hopital Cochin
Paris, France, 75014
CHU Purpan
Toulouse, France, 31059
CHRU Trousseau
Tours, France, 37044
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: PANIS Yves, Pr Assistance Publique - Hôpitaux de Paris
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cécile Jourdain, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00554892     History of Changes
Other Study ID Numbers: P060233
AOM 06086
IDRCB 2007-A00471
First Submitted: November 6, 2007
First Posted: November 7, 2007
Last Update Posted: June 30, 2010
Last Verified: June 2010

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Rectal cancer
Sphincter preservation
Mechanical bowel preparation
Post operative morbidity
Anastomotic leakage

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