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 ]

Conversion means that events required additional port(s) or open laparotomy


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