Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
short-term morbidity rate
30 days
No
Marco Braga, MD
Study Director
San Raffaele Vita-Salute University
Italy: Ethics Committee
hmsxLPS09
NCT00894725
February 2000
December 2008
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