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ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation

18 Years
Not Enrolling
Patients With Rectal Cancer

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Trial Information

ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation

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.

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

Exclusion Criteria:

- Stage IV disease

- Comorbidity with post operative infectious risk corticoids,immunodeficiency, Crohn's
disease, ulcerative colitis ...)

- Abdominoperineal resection

- Emergency surgery

Type of Study:


Study Design:

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

Outcome Measure:

Overall morbidity including infectious and non infectious complications

Outcome Time Frame:

peri operative

Safety Issue:


Principal Investigator

PANIS Yves, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

September 2007

Completion Date:

August 2009

Related Keywords:

  • Patients With Rectal Cancer
  • Rectal cancer
  • Sphincter preservation
  • Mechanical bowel preparation
  • Post operative morbidity
  • Anastomotic leakage
  • Rectal Neoplasms