Barbed Suture in Single-port Laparoscopic Myomectomy

Uterine Myoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984632
• Other study ID #: MYO04
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2013
• Last updated: July 30, 2015
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: CHA University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review BoardSouth Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Myoma

Intervention

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).
• 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).

Locations

Country	Name	City	State
Korea, Republic of	National Health Insurance Service Ilsan Hospital	Goyang
Korea, Republic of	CHA Gangnam Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CHA University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suturing time	the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy	Intra-operative	No
Secondary	Cosmetic satisfaction	We will compare patient's cosmetic satisfaction through self-reported questionnaire (Body image Questionnaire).	Post-surgery 1 month and 3 month	No