NCT01483417

Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

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 Adenomyosis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: Female
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Myoma
• Uterine Adenomyosis

Interventions

Type	Name	Description
PROCEDURE	Single incision Laparoscopic hysterectomy	SILS port
PROCEDURE	Conventional laparoscopic hysterectomy	3-4 conventional ports

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2011-12-01
• Last updated: 2012-02-22

Locations

8 sites across 1 country: South Korea