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Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.
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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.
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60 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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