Rectal Cancer Surgery Without Mechanical Bowel Preparation

Patients With Rectal Cancer Clinical Trial

— PREPACOL  

Official title:

ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554892
• Other study ID #: P060233
• Secondary ID: AOM 06086IDRCB 2
• Status: Completed
• Phase: N/A
• First received: November 6, 2007
• Last updated: June 29, 2010
• Start date: September 2007
• Est. completion date: August 2009

Study information

• Verified date: June 2010
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this controlled multicentric study is to assess rectal cancer surgery with sphincter preservation without pre operative mechanical bowel preparation

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: August 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patients With Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• bowel preparation
oral laxatives, retrograde enemas
• no preparation bowel
no preparation bowel

Locations

Country	Name	City	State
France	CHU	Angers
France	Hopital Saint André	Bordeaux
France	Hopital Ambroise Paré	Boulognes Billancourt
France	CHU	Clermont-Ferrand
France	Hôpital Beaujon	Clichy
France	Hopital Nord	Marseille
France	Institut Paoli Calmette	Marseille
France	CRLC Val d'Aurelle	Montpellier
France	Hopital Cochin	Paris
France	CHU Purpan	Toulouse
France	CHRU Trousseau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall morbidity including infectious and non infectious complications		peri operative	No
Secondary	- peri operative mortality - non infectious morbidity - anastomotic leakage - hospital stay - per operative evaluation of bowel preparation - clinical evaluation of bowel preparation		30 days, 6 months	No
Secondary	Evaluate the postoperative complications classified according to the DINDO classification.		during the study	No