Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

Phase 3

• Conditions: Uterine Myoma; Uterine Adenomyosis
• Interventions: Procedure: Single incision Laparoscopic hysterectomy; Procedure: Conventional laparoscopic hysterectomy

• Registration Number: NCT01483417
• Lead Sponsor: Samsung Medical Center

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 Description

Not available

Study Timeline

• Status Verified: 2011-11
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-11-29
• Study Start: 2011-12
• Study First Posted: 2011-12-01
• Last Update Submitted: 2012-02-20
• Last Update Posted: 2012-02-22
• Primary Completion: 2012-12
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Symptomatic (dysmenorrhea, palpable mass, pelvic pain or discomfort urinary symptom, increasing size, menorrhagia) myomas or adenomyomas
• Uterine size < gestational age of 14 weeks
• Informed consent

Exclusion Criteria

• Medical diseases such as heart failure, renal insufficiency, liver cirrhosis, pancreatitis, uncontrolled DM
• Huge uterine size > gestational age of 14 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SILS	Single incision Laparoscopic hysterectomy	Laparoscopic hysterectomy including LAVH, LH(a), and TLH using SILS port
Conventional multi-port laparoscopic hysterectomy	Conventional laparoscopic hysterectomy	3-4 ports laparoscopic hysterectomy including LAVH, LH(a), or TLH

Primary Outcome Measures

Name	Time	Method
Conversion rate	1 week	Conversion means that events required additional port(s) or open laparotomy

Secondary Outcome Measures

Name	Time	Method
Patient and Observer Scar Assessment Scale (POSAS)	12 weeks
Postoperative pain	postop. 1 day, 1 week	Measured by numeric rating score (NRS)

Trial Locations

Locations (8)

Catholic Incheon Hospital; 🇰🇷 Incheon, Korea, Republic of

Yonsei University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Keimyung University Dongsan Hospital; 🇰🇷 Deagu, Korea, Republic of

Kangnam Cha Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul University Bundang Hospital; 🇰🇷 Seungnam, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul Catholic Medical Center; 🇰🇷 Seoul, Korea, Republic of