Cholelithiasis Clinical Trial
Official title:
Single Incision Versus Laparoscopic Cholecystectomy
Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.
This will be a prospective, randomized clinical trial involving patients who present to the
hospital with an indication for cholecystectomy. We will offer enrollment to several
institutions provided they receive institutional approval.
This will be a definitive trial design. Based on our operative times with SILS compared with
our recent experience in standard laparoscopy, a sample size of 60 patients will give us a
power of 0.8 with an α of 0.05.
After the procedure, both groups will be managed in the same manner per routine care. They
will be discharged when tolerating a regular diet and their pain is well-controlled on oral
pain medication.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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