Colorectal Surgery Clinical Trial
Official title:
Prospective, Controlled, Randomized Study of Intraoperative Colonic Irrigation vs. Stent Placement in Obstructive Left-Sided Colonic Cancer
INTRODUCTION: There are several alternatives for one-stage emergency treatment of
obstructive left-sided colonic cancer (OLCC): subtotal colectomy, intraoperative colon
lavage (IOCL) with primary anastomosis, and the placement of a stent as a temporary measure
prior to scheduled surgery. At present, it is not clear whether emergency perioperative
lavage or the placement of a stent is the better technique. The hypothesis is that IOCL and
primary anastomosis is equal safe or even safer than placement of a stent as a temporary
measure prior to scheduled surgery, less length of stay and less cost.
OBJECTIVE: To establish which of these two techniques is more efficient in OLCC from the
point of view of morbimortality, economic cost, and long-term survival.
MATERIAL AND METHODS:
Prospective, controlled, randomized study of patients diagnosed with OLCC. Patients were
divided into two groups: group 1: stent and deferred surgery; group 2: emergency IOCL. A
simple randomization system was used. The estimated sample size required per group was 21
patients. Demographic variables, risk prediction models, postoperative morbimortality,
staging, complications due to the placement of stent, surgical time, clinical follow-up,
health costs and follow-up of survival were recorded.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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