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Completed

NCT Number: NCT00554892

Rectal Cancer Surgery Without Mechanical Bowel Preparation

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bowel preparation

Procedure

oral laxatives, retrograde enemas

no preparation bowel

Procedure

no preparation bowel

Primary outcomes

  1. Overall morbidity including infectious and non infectious complications

    Time frame: peri operative

Secondary outcomes

  1. - 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

  2. Evaluate the postoperative complications classified according to the DINDO classification.

    Time frame: during the study

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation

Acronym: PREPACOL

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 7, 2007
Registry last updated
Jun 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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