Clinical Trial: SILS™ Port Laparoscopic Cholecystectomy Post Market Study
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy
Brief Summary:
The objectives of this trial are:
- to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy
- monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC to objectively document the scientific merit and the perceived advantages of SILS™ Port Laparoscopic Cholecystectomy.
Detailed Summary:
Sponsor: Medtronic - MITG
Current Primary Outcome: Feasibility and safety of SILS™ port cholecystectomy versus 4PLC as indicated by intraoperative and postoperative adverse events. [ Time Frame: Ten time points out to one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pain [ Time Frame: Seven time points ]
- Quality of life/ time to return to normal activity [ Time Frame: Six time points ]
- Cosmesis [ Time Frame: Five time points ]
Original Secondary Outcome: Same as current
Information By: Medtronic - MITG
Dates:
Date Received: January 29, 2009
Date Started: April 2009
Date Completion: August 2012
Last Updated: July 31, 2012
Last Verified: January 2012