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:

  1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy
  2. 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