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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall morbidity including infectious and non infectious complications
peri operative
No
PANIS Yves, Pr
Principal Investigator
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health
P060233
NCT00554892
September 2007
August 2009
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