Rectal Cancer Surgery Without Mechanical Bowel Preparation

Condition(s) targeted: Patients With Rectal Cancer

Intervention: bowel preparation (Procedure); no preparation bowel (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
PANIS Yves, Pr, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris

Overall contact:
PANIS Yves, Pr, Phone: +33 1 .40.87.45.47, Email: yves.panis@bjn.aphp.fr

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

Official title: ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Overall morbidity including infectious and non infectious complications

Secondary outcome: - peri operative mortality - non infectious morbidity - anastomotic leakage - hospital stay - per operative evaluation of bowel preparation - clinical evaluation of 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

PANIS Yves, Pr, Phone: +33 1 .40.87.45.47, Email: yves.panis@bjn.aphp.fr

Hôpital Beaujon, Clichy 92110, France; Recruiting
PANIS Yves, Pr, Phone: +33 1 40 87 45 47, Email: yves.panis@bjn.aphp.fr

Hopital Nord, Marseille 13000, France; Recruiting
BERDAH Stéphane, Pr, Phone: +33-4 91 96 88 25, Email: stephane.berdah@mail.ap-hm.fr
MOUTARDIER Vincent, Dr, Phone: +33-4 91 96 88 25, Email: vincent.moutardier@mail.ap-hm.fr

CHU, Angers 49000, France; Recruiting
ARNAUD Jean-Pierre, Pr, Phone: +33-2 41 35 36 18, Email: JPArnaud@chu-angers.fr
LERMITE Emilie, Dr, Phone: +33-2 41 35 36 18, Email: lermiteemilie@yahoo.fr

CHU, Clermont-Ferrand 63000, France; Recruiting
CHIPPONI Jasques, Pr, Phone: +33 4 73 75 04 94, Email: jchipponi@chu-clermontferrand.fr

Hopital Cochin, Paris 75014, France; Recruiting
DOUSSET Bertrand, Pr, Phone: +33 1 58 41 17 24, Email: bertrand.dousset@cch.aphp.fr

CRLC Val d'Aurelle, Montpellier 34298, France; Recruiting
ROUANET Philippe, Pr, Phone: +33 4 67 61 30 71, Email: prouanet@valdorel.fnclcc.fr

Hopital Saint André, Bordeaux 33075, France; Recruiting
RULLIER Eric, Pr, Phone: +33 5 56 79 58 10, Email: eric.rullier@chu-bordeaux.fr

CHU Purpan, Toulouse 31059, France; Recruiting
PORTIER Guillaume, Pr, Phone: +33 5 61 77 25 30, Email: portier.g@chu-toulouse.fr

Hopital Ambroise Paré, Boulognes Billancourt 92100, France; Recruiting
BENOIST Stéphane, Pr, Phone: +33 149 09 45 45, Email: stéphane.benoist@apr.aphp.fr

Institut Paoli Calmette, Marseille 13273, France; Recruiting
BEGE Thierry, Dr, Phone: +33 4 91 22 30 95

CHRU Trousseau, Tours 37044, France; Recruiting
DE LA LANDE DE CALAN Loic, Pr, Phone: +33 2 47 47 81 23, Email: decalan@med.univ-tours.fr

Starting date: September 2007
Ending date: February 2010
Last updated: November 6, 2007