NCT01483417

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

February 22, 2012

Status Verified

November 1, 2011

Enrollment Period

1 year

First QC Date

November 29, 2011

Last Update Submit

February 20, 2012

Conditions

Uterine MyomaUterine Adenomyosis

Keywords

SILSLaparoscopic hysterectomyCosmetic outcomePain

Outcome Measures

Primary Outcomes (1)

  • Conversion rate

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

    1 week

Secondary Outcomes (2)

  • Patient and Observer Scar Assessment Scale (POSAS)

    12 weeks

  • Postoperative pain

    postop. 1 day, 1 week

Study Arms (2)

SILS

EXPERIMENTAL

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

Procedure: Single incision Laparoscopic hysterectomy

Conventional multi-port laparoscopic hysterectomy

ACTIVE COMPARATOR

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

Procedure: Conventional laparoscopic hysterectomy

Interventions

Single incision Laparoscopic hysterectomyPROCEDURE

SILS port

SILS
Conventional laparoscopic hysterectomyPROCEDURE

3-4 conventional ports

Conventional multi-port laparoscopic hysterectomy

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Keimyung University Dongsan Hospital

Deagu, South Korea

RECRUITING

Catholic Incheon Hospital

Incheon, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

NOT YET RECRUITING

Kangnam Cha Hospital

Seoul, South Korea

RECRUITING

Seoul Catholic Medical Center

Seoul, South Korea

NOT YET RECRUITING

Yonsei University Medical Center

Seoul, South Korea

NOT YET RECRUITING

Seoul University Bundang Hospital

Seungnam, South Korea

NOT YET RECRUITING

Related Publications (4)

  • 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.

    PMID: 20177921BACKGROUND

  • 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.

    PMID: 19487164BACKGROUND

  • 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.

    PMID: 21298522BACKGROUND

  • 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.

    PMID: 21422864BACKGROUND

MeSH Terms

Conditions

MyofibromaAdenomyosisPain

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chi-Heum Cho, MD, PhD

    Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Heum Cho, MD, PhD

CONTACT

c0035@dsmc.or.kr

Sang Hun Kwon, MD, PhD

CONTACT

ksh1999@dsmc.or.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 1, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

February 22, 2012

Record last verified: 2011-11

Locations

KR(8)