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Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy

2014-08-27 03:19:11 | BioPortfolio

Summary

Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.

Description

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 Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cholelithiasis

Intervention

SILS, Standard Laparoscopic Cholecystectomy

Location

Children's Mercy Hospital
Kansas City
Missouri
United States
64108

Status

Recruiting

Source

Children's Mercy Hospital Kansas City

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:11-0400

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Medical and Biotech [MESH] Definitions

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