Rectal Cancer Surgery Without Mechanical Bowel Preparation

NCT ID: NCT00554892

Last Updated: 2010-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-08-31

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.

Conditions

Patients With Rectal Cancer

Keywords

Rectal cancer; Sphincter preservation; Mechanical bowel preparation; Post operative morbidity; Anastomotic leakage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Bowel preparation

Group Type: ACTIVE_COMPARATOR

bowel preparation

Intervention Type: PROCEDURE

oral laxatives, retrograde enemas

2

without bowel preparation

Group Type: EXPERIMENTAL

no preparation bowel

Intervention Type: PROCEDURE

no preparation bowel

Interventions

bowel preparation

oral laxatives, retrograde enemas

Intervention Type: PROCEDURE

no preparation bowel

no preparation bowel

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department Clinical Research of Developpement

Principal Investigators

PANIS Yves, Pr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 21037443 (View on PubMed)

Other Identifiers

AOM 06086

Identifier Type: -

Identifier Source: secondary_id

IDRCB 2007-A00471

Identifier Type: -

Identifier Source: secondary_id

P060233

Identifier Type: -

Identifier Source: org_study_id