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Barbed Suture in Single-port Laparoscopic Myomectomy

Primary Purpose

Uterine Myoma

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Single-port laparoscopic myomectomy

Multi-port laparoscopic myomectomy

About this trial

This is an interventional treatment trial for Uterine Myoma

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

National Health Insurance Service Ilsan Hospital
CHA Gangnam Medical Center
Kangbuk Samsung Hospital
Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single-port laparoscopic myomectomy

Multi-port laparoscopic myomectomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Suturing time

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

Secondary Outcome Measures

Cosmetic satisfaction

We will compare patient's cosmetic satisfaction through self-reported questionnaire (Body image Questionnaire).

Full Information

NCT ID

NCT01984632

First Posted

November 3, 2013

Last Updated

July 30, 2015

Sponsor

CHA University

1. Study Identification

Unique Protocol Identification Number

NCT01984632

Brief Title

Barbed Suture in Single-port Laparoscopic Myomectomy

Official Title

Single-port Laparoscopic Myomectomy Using Barbed Suture Versus Multi-port One: a Multi-center Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

CHA University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The investigators plan to perform a multi-center randomized clinical trial on women scheduled for laparoscopic myomectomy. All women will get the same preoperative and postoperative care. Women will be assigned by chance to one of two groups: one group will receive single-port laparoscopic myomectomy using V-Loc™ suture material (study group). The other group will receive conventional multi-port laparoscopic myomectomy using V-Loc™ suture material (control group). The investigators will collect information on suturing time and complications related to surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Myoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single-port laparoscopic myomectomy

Arm Type

Experimental

Arm Description

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

Arm Title

Multi-port laparoscopic myomectomy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Single-port laparoscopic myomectomy

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

Multi-port laparoscopic myomectomy

Intervention Description

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).

Primary Outcome Measure Information:

Title

Suturing time

Description

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

Time Frame

Intra-operative

Secondary Outcome Measure Information:

Title

Cosmetic satisfaction

Description

We will compare patient's cosmetic satisfaction through self-reported questionnaire (Body image Questionnaire).

Time Frame

Post-surgery 1 month and 3 month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Taejong Song, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Health Insurance Service Ilsan Hospital

City

Goyang

Country

Korea, Republic of

Facility Name

CHA Gangnam Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Kangbuk Samsung Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

26263079

Citation

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.

Results Reference

derived

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Barbed Suture in Single-port Laparoscopic Myomectomy

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