Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

This study is currently recruiting participants.

Verified November 2011 by Samsung Medical Center

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

History of Changes

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:

MedlinePlus related topics: Hysterectomy

U.S. FDA Resources

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

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:

Kim TJ, Lee YY, Cha HH, Kim CJ, Choi CH, Lee JW, Bae DS, Lee JH, Kim BG. Single-port-access laparoscopic-assisted vaginal hysterectomy versus conventional laparoscopic-assisted vaginal hysterectomy: a comparison of perioperative outcomes. Surg Endosc. 2010 Sep;24(9):2248-52. Epub 2010 Feb 23.

Lee YY, Kim TJ, Kim CJ, Kang H, Choi CH, Lee JW, Kim BG, Lee JH, Bae DS. Single-port access laparoscopic-assisted vaginal hysterectomy: a novel method with a wound retractor and a glove. J Minim Invasive Gynecol. 2009 Jul-Aug;16(4):450-3. Epub 2009 May 31.

Jung YW, Lee M, Yim GW, Lee SH, Paek JH, Kwon HY, Nam EJ, Kim SW, Kim YT. A randomized prospective study of single-port and four-port approaches for hysterectomy in terms of postoperative pain. Surg Endosc. 2011 Aug;25(8):2462-9. Epub 2011 Feb 7.

Chen YJ, Wang PH, Ocampo EJ, Twu NF, Yen MS, Chao KC. Single-port compared with conventional laparoscopic-assisted vaginal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2011 Apr;117(4):906-12.

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 May 16, 2013

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