Barbed Suture in Single-port Laparoscopic Myomectomy

Sponsor

CHA University (Other)

Overall Status

Completed

CT.gov ID

NCT01984632

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Myoma	Procedure: Single-port laparoscopic myomectomy Procedure: Multi-port laparoscopic myomectomy	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single-port laparoscopic myomectomy We will use barbed suture (V-Loc) under intervention of single-port laparoscopic myomectomy	Procedure: Single-port laparoscopic myomectomy 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).
Active Comparator: Multi-port laparoscopic myomectomy We will use barbed suture(V-Loc) under intervention of multi-port laparoscopic myomectomy.	Procedure: Multi-port laparoscopic myomectomy 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).

Arm

Intervention/Treatment

Experimental: Single-port laparoscopic myomectomy

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

Procedure: Single-port laparoscopic myomectomy

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).

Active Comparator: Multi-port laparoscopic myomectomy

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

Procedure: Multi-port laparoscopic myomectomy

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).

Outcome Measures

Primary Outcome Measures

Suturing time [Intra-operative]
the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy

Secondary Outcome Measures

Cosmetic satisfaction [Post-surgery 1 month and 3 month]
We will compare patient's cosmetic satisfaction through self-reported questionnaire (Body image Questionnaire).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	National Health Insurance Service Ilsan Hospital	Goyang	Korea, Republic of
2	CHA Gangnam Medical Center	Seoul	Korea, Republic of
3	Kangbuk Samsung Hospital	Seoul	Korea, Republic of
4	Samsung Medical Center	Seoul	Korea, Republic of

Sponsors and Collaborators

CHA University

Investigators

Principal Investigator: Taejong Song, MD, CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taejong Song, Professor, CHA University

ClinicalTrials.gov Identifier:

NCT01984632

Other Study ID Numbers:

MYO04

First Posted:

Nov 15, 2013

Last Update Posted:

Jul 31, 2015

Last Verified:

Jul 1, 2015

Additional relevant MeSH terms:

Leiomyoma

Myofibroma

Study Results

No Results Posted as of Jul 31, 2015