Randomized Trial Comparing Drainage Versus no Drainage Following Rectal Excision With Low Anastomosis for Rectal Cancer
After rectal excision, the rate of anastomotic leak and abscess is higher than after colic
surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a
prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness
of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice
had never been evaluated in patients with rectal excision and low anastomosis (patients with
a high risk of pelvic sepsis) The aim of the study is to assess the impact of pelvic
drainage vs. non pelvic drainage on risk of pelvic sepsis after rectal excision for cancer
with infraperitoneal anastomosis. The principal objective is to compare the rate of pelvic
sepsis until 30 days between the 2 groups of patients who had a rectal excision with and
without pelvic drainage. It is a randomized clinical trial of superiority, multicentric,
without blinding, in 2 parallel groups with ratio (1:1): distribution of the number of
patients in the groups.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Pelvic sepsis
Pelvic sepsis until 30 days after rectal excision is the primary end point. It is defined as the occurrence of an anastomotic leak revealed by peritonitis or discharge of gas, stools or pus, the vagina or the abdominal wound, and/or a pelvic abscess, between J0 and J30.
within the first 30 days after surgery
Yes
Adélaïde Doussau, Dr
Study Chair
University Hospital, Bordeaux
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
CHUBX 2010/24
NCT01269567
January 2011
December 2013
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