Clinical trial NCT00554892: Rectal Cancer Surgery Without Mechanical Bowel Preparation
Official title: ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Rectal Cancer
Keywords: Rectal cancer
Sphincter preservation
Mechanical bowel preparation
Post operative morbidity
Anastomotic leakage
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-11-07
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall morbidity including infectious and non infectious complications
timeFrame: peri operative
Secondary outcomes:
measure: - peri operative mortality - non infectious morbidity - anastomotic leakage - hospital stay - per operative evaluation of bowel preparation - clinical evaluation of bowel preparation
timeFrame: 30 days, 6 months
measure: Evaluate the postoperative complications classified according to the DINDO classification.
timeFrame: during the study
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU
city: Bordeaux
country: France
facility: Hopital Saint André
city: Boulognes Billancourt
country: France
facility: Hopital Ambroise Paré
city: Clermont-Ferrand
country: France
facility: CHU
city: Clichy
country: France
facility: Hôpital Beaujon
city: Marseille
country: France
facility: Hopital Nord
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Montpellier
country: France
facility: CRLC Val d'Aurelle
city: Paris
country: France
facility: Hopital Cochin
city: Toulouse
country: France
facility: CHU Purpan
city: Tours
country: France
facility: CHRU Trousseau
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: PANIS Yves, Pr
role: PRINCIPAL_INVESTIGATOR
References:
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.