NCT01984632

Brief Summary

The aim of this study is to test our hypothesis that the use of unidirectional knotless barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine wall defect after myoma enucleation as multi-port laparoscopic myomectomy did.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

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

Study Start

First participant enrolled

November 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.1 years

First QC Date

November 3, 2013

Last Update Submit

July 30, 2015

Conditions

Uterine Myoma

Outcome Measures

Primary Outcomes (1)

  • Suturing time

    the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy

    Intra-operative

Secondary Outcomes (1)

  • Cosmetic satisfaction

    Post-surgery 1 month and 3 month

Study Arms (2)

Single-port laparoscopic myomectomy

EXPERIMENTAL

We will use barbed suture (V-Loc) under intervention of single-port laparoscopic myomectomy

Procedure: Single-port laparoscopic myomectomy

Multi-port laparoscopic myomectomy

ACTIVE COMPARATOR

We will use barbed suture(V-Loc) under intervention of multi-port laparoscopic myomectomy.

Procedure: Multi-port laparoscopic myomectomy

Interventions

Single-port laparoscopic myomectomyPROCEDURE

The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture (control group) in terms of operative time (esp. suturing time).

Single-port laparoscopic myomectomy
Multi-port laparoscopic myomectomyPROCEDURE

The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture(control group) in terms of operative time (esp. suturing time).

Multi-port laparoscopic myomectomy

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 55 years
  • Image-confirmed uterine myoma
  • Number of myoma ≤2 and largest size ≤10cm
  • Women who were scheduled to have laparoscopic myomectomy
  • Appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)

You may not qualify if:

  • Women with pedunculated subserosal myoma or submucosal myoma
  • Women undergoing concomitant complex surgical procedures at the time of laparoscopic myomectomy such as severe adhesiolysis or resection for severe endometriosis
  • Women with any suggestion of malignant uterine or adnexal diseases
  • Women with diabetics, malignancy, or malnutrition, which can affect wound healing
  • Women having major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance
  • Women who refuse to participate or give consent to the procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

National Health Insurance Service Ilsan Hospital

Goyang, South Korea

Location

CHA Gangnam Medical Center

Seoul, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • Song T, Kim TJ, Lee SH, Kim TH, Kim WY. Laparoendoscopic single-site myomectomy compared with conventional laparoscopic myomectomy: a multicenter, randomized, controlled trial. Fertil Steril. 2015 Nov;104(5):1325-31. doi: 10.1016/j.fertnstert.2015.07.1137. Epub 2015 Aug 8.

    PMID: 26263079DERIVED

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Taejong Song, MD

    CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea

    PRINCIPAL INVESTIGATOR

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
Professor

Study Record Dates

First Submitted

November 3, 2013

First Posted

November 15, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

KR(4)