Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Tae-Joong Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01483417
First received: November 29, 2011
Last updated: February 20, 2012
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Uterine Myoma
Uterine Adenomyosis
Procedure: Single incision Laparoscopic hysterectomy
Procedure: Conventional laparoscopic hysterectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Adenomyosis

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Conversion rate [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Conversion means that events required additional port(s) or open laparotomy


Secondary Outcome Measures:
  • Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Postoperative pain [ Time Frame: postop. 1 day, 1 week ] [ Designated as safety issue: No ]
    Measured by numeric rating score (NRS)


Estimated Enrollment: 240
Study Start Date: December 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483417

Contacts
Contact: Chi-Heum Cho, MD, PhD c0035@dsmc.or.kr
Contact: Sang Hun Kwon, MD, PhD ksh1999@dsmc.or.kr

Locations
Korea, Republic of
Keimyung University Dongsan Hospital Recruiting
Deagu, Korea, Republic of
Contact: Chi-Heum Cho, MD,PhD         
Catholic Incheon Hospital Not yet recruiting
Incheon, Korea, Republic of
Contact: Yong Wook Kim         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Tae Joong Kim, MD    82-2-3410-3547    tj28.kim@gmail.com   
Principal Investigator: Tae Joong Kim         
Seoul Catholic Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Soo Young Hur         
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Yong Man Kim         
Yonsei University Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Sang Wun Kim         
Kangnam Cha Hospital Recruiting
Seoul, Korea, Republic of
Contact: Suk Joo Sung         
Seoul University Bundang Hospital Not yet recruiting
Seungnam, Korea, Republic of
Contact: Yong Beom Kim         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Chi-Heum Cho, MD, PhD Keimyung University Dongsan Medical Center
  More Information

Publications:
Responsible Party: Tae-Joong Kim, Clinical Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01483417     History of Changes
Other Study ID Numbers: 2011-10-004
Study First Received: November 29, 2011
Last Updated: February 20, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
SILS
Laparoscopic hysterectomy
Cosmetic outcome
Pain

Additional relevant MeSH terms:
Myoma
Leiomyoma
Myofibroma
Endometriosis
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014