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Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

Primary Purpose

Uterine Myoma, Uterine Adenomyosis

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Single incision Laparoscopic hysterectomy
Conventional laparoscopic hysterectomy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Myoma focused on measuring SILS, Laparoscopic hysterectomy, Cosmetic outcome, Pain

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Keimyung University Dongsan HospitalRecruiting
  • Catholic Incheon Hospital
  • Samsung Medical CenterRecruiting
  • Asan Medical Center
  • Kangnam Cha HospitalRecruiting
  • Seoul Catholic Medical Center
  • Yonsei University Medical Center
  • Seoul University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SILS

Conventional multi-port laparoscopic hysterectomy

Arm Description

Laparoscopic hysterectomy including LAVH, LH(a), and TLH using SILS port

3-4 ports laparoscopic hysterectomy including LAVH, LH(a), or TLH

Outcomes

Primary Outcome Measures

Conversion rate
Conversion means that events required additional port(s) or open laparotomy

Secondary Outcome Measures

Patient and Observer Scar Assessment Scale (POSAS)
Postoperative pain
Measured by numeric rating score (NRS)

Full Information

First Posted
November 29, 2011
Last Updated
February 20, 2012
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01483417
Brief Title
Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Myoma, Uterine Adenomyosis
Keywords
SILS, Laparoscopic hysterectomy, Cosmetic outcome, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SILS
Arm Type
Experimental
Arm Description
Laparoscopic hysterectomy including LAVH, LH(a), and TLH using SILS port
Arm Title
Conventional multi-port laparoscopic hysterectomy
Arm Type
Active Comparator
Arm Description
3-4 ports laparoscopic hysterectomy including LAVH, LH(a), or TLH
Intervention Type
Procedure
Intervention Name(s)
Single incision Laparoscopic hysterectomy
Intervention Description
SILS port
Intervention Type
Procedure
Intervention Name(s)
Conventional laparoscopic hysterectomy
Intervention Description
3-4 conventional ports
Primary Outcome Measure Information:
Title
Conversion rate
Description
Conversion means that events required additional port(s) or open laparotomy
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Patient and Observer Scar Assessment Scale (POSAS)
Time Frame
12 weeks
Title
Postoperative pain
Description
Measured by numeric rating score (NRS)
Time Frame
postop. 1 day, 1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi-Heum Cho, MD, PhD
Email
c0035@dsmc.or.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Hun Kwon, MD, PhD
Email
ksh1999@dsmc.or.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-Heum Cho, MD, PhD
Organizational Affiliation
Keimyung University Dongsan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung University Dongsan Hospital
City
Deagu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi-Heum Cho, MD,PhD
Facility Name
Catholic Incheon Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Wook Kim
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Joong Kim, MD
Phone
82-2-3410-3547
Email
tj28.kim@gmail.com
First Name & Middle Initial & Last Name & Degree
Tae Joong Kim
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Man Kim
Facility Name
Kangnam Cha Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suk Joo Sung
Facility Name
Seoul Catholic Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Young Hur
Facility Name
Yonsei University Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Wun Kim
Facility Name
Seoul University Bundang Hospital
City
Seungnam
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Beom Kim

12. IPD Sharing Statement

Citations:
PubMed Identifier
20177921
Citation
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. doi: 10.1007/s00464-010-0944-y. Epub 2010 Feb 23.
Results Reference
background
PubMed Identifier
19487164
Citation
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. doi: 10.1016/j.jmig.2009.03.022. Epub 2009 May 31.
Results Reference
background
PubMed Identifier
21298522
Citation
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. doi: 10.1007/s00464-010-1567-z. Epub 2011 Feb 7.
Results Reference
background
PubMed Identifier
21422864
Citation
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):906-912. doi: 10.1097/AOG.0b013e31820c666a.
Results Reference
background

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Single Incision Laparoscopic Surgery (SILS) Versus Conventional Laparoscopic Hysterectomy

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