Colon Cancer Clinical Trial
Official title:
Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial
The main goal of this study is to clarify if laparoscopy (LPS) could become the standard
approach in patients undergoing left colonic resection.
268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or
open (n=134) approach. Postoperative care protocol was the same in both groups. Trained
members of the surgical staff who were not involved in the study registered 30-day
postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term
morbidity, quality of life, and 5-year survival have also been evaluated.
The study design was explained to the potential participants who were asked to sign a
written informed consent before randomization.
Eligible patients were randomly allocated to LPS or open surgery. Randomization list was
computer generated. Assignments were made by means of sealed sequenced masked envelopes
which were opened, before the induction of anesthesia, by a nurse unaware of the trial
design.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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