Rectal Cancer Surgery Without Mechanical Bowel Preparation (PREPACOL)
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation |
- Overall morbidity including infectious and non infectious complications [ Time Frame: peri operative ] [ Designated as safety issue: No ]
- - 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 ] [ Designated as safety issue: No ]
- Evaluate the postoperative complications classified according to the DINDO classification. [ Time Frame: during the study ] [ Designated as safety issue: No ]
| 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
Other Name: bowel preparation
|
|
Experimental: 2
without bowel preparation
|
Procedure: no preparation bowel
no preparation bowel
Other Name: 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| Institut Paoli Calmette | |
| Marseille, France, 13273 | |
| Hopital Nord | |
| Marseille, France, 13000 | |
| CRLC Val d'Aurelle | |
| Montpellier, France, 34298 | |
| Hopital Cochin | |
| Paris, France, 75014 | |
| CHU Purpan | |
| Toulouse, France, 31059 | |
| CHRU Trousseau | |
| Tours, France, 37044 | |
| Principal Investigator: | PANIS Yves, Pr | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided by Assistance Publique - Hôpitaux de Paris
Additional 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 |
| Study First Received: | November 6, 2007 |
| Last Updated: | June 29, 2010 |
| Health Authority: | France: Ministry of Health |
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 |
ClinicalTrials.gov processed this record on June 18, 2013