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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Single Incision Laparoscopic Cholecystectomy
4 port technique
Children's Mercy Hospital
Kansas City, Missouri, United States
Operative Time
Time frame: 1 day
Operative complications
Time frame: 2 weeks
length of hospitalization
Time frame: 1 week
doses of analgesics
Time frame: 1 week
hospital/operation charges
Time frame: 1 week
surgeon perception of difficulty
Time frame: 1 day
cosmetic scores
Time frame: 6 months
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