Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

February 20, 2012 updated by: Tae-Joong Kim, Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Deagu, Korea, Republic of
        • Recruiting
        • Keimyung University Dongsan Hospital
        • Contact:
          • Chi-Heum Cho, MD,PhD
      • Incheon, Korea, Republic of
        • Not yet recruiting
        • Catholic Incheon hospital
        • Contact:
          • Yong Wook Kim
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Tae Joong Kim
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Asan Medical Center
        • Contact:
          • Yong Man Kim
      • Seoul, Korea, Republic of
        • Recruiting
        • Kangnam Cha Hospital
        • Contact:
          • Suk Joo Sung
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Seoul Catholic Medical Center
        • Contact:
          • Soo Young Hur
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Yonsei University Medical Center
        • Contact:
          • Sang Wun Kim
      • Seungnam, Korea, Republic of
        • Not yet recruiting
        • Seoul university Bundang hospital
        • Contact:
          • Yong Beom Kim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SILS
Laparoscopic hysterectomy including LAVH, LH(a), and TLH using SILS port
Procedure: Single incision Laparoscopic hysterectomy
SILS port
Active Comparator: Conventional multi-port laparoscopic hysterectomy
3-4 ports laparoscopic hysterectomy including LAVH, LH(a), or TLH
Procedure: Conventional laparoscopic hysterectomy
3-4 conventional ports

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion rate
Time Frame: 1 week
Conversion means that events required additional port(s) or open laparotomy
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: 12 weeks
12 weeks
Postoperative pain
Time Frame: postop. 1 day, 1 week
Measured by numeric rating score (NRS)
postop. 1 day, 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Chi-Heum Cho, MD, PhD, Keimyung University Dongsan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

November 29, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

December 1, 2011

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 20, 2012

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-10-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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