Clinical Trial: Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy: A Randomized Prospective Trial
Brief Summary: This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.
Detailed Summary: Single-Incision Laparoscopic Surgery (SILS) is accepted as a form of surgical treatment. Traditional laparoscopic cholecystectomy (TLC) is well tolerated, with a low complication risk and high patient satisfaction; thus a SILS procedure needs to be at least equivalent to be a justifiable replacement, and should not result in higher costs.
Sponsor: Saint Luke's Health System
Current Primary Outcome: Cost associated with performance of the procedure and post-operative care until discharge [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pain scale reported by patient at discharge, 24 and 48 hours [ Time Frame: 24 hours and 48 hours ]
- Amount of pain medicine required during 48 hours after surgery [ Time Frame: 48 hours ]
- Major and minor gastrointestinal surgical complications, including conversion [ Time Frame: 4 weeks ]
- Quality of Life [ Time Frame: 2 weeks and 4 weeks ]
Original Secondary Outcome: Same as current
Information By: Saint Luke's Health System
Dates:
Date Received: September 2, 2010
Date Started: February 2010
Date Completion:
Last Updated: April 27, 2012
Last Verified: August 2011
