Clinical Trial: Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Multi-institution, Randomized Trial for Efficacy and Safety of Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy for the Treatment of Uterine Myoma or
Brief Summary: Multi-center prospective randomized trial of single port laparoscopic surgery (SILS) versus conventional 3-4 ports laparoscopic hysterectomy. Hypothesis is that conversion rate of SILS is not inferior to that of conventional approach.
Detailed Summary:
Sponsor: Samsung Medical Center
Current Primary Outcome: Conversion rate [ Time Frame: 1 week ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: 12 weeks ]
- Postoperative pain [ Time Frame: postop. 1 day, 1 week ]Measured by numeric rating score (NRS)
Original Secondary Outcome: Same as current
Information By: Samsung Medical Center
Dates:
Date Received: November 29, 2011
Date Started: December 2011
Date Completion: March 2013
Last Updated: February 20, 2012
Last Verified: November 2011