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Completed

NCT Number: NCT01984632

Barbed Suture in Single-port Laparoscopic Myomectomy

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.

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Key information

Conditions

Uterine Myoma Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

National Health Insurance Service Ilsan Hospital, Goyang, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single-port laparoscopic myomectomy

Procedure

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

Procedure

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 outcomes

  1. Suturing time

    Time frame: Intra-operative

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

Secondary outcomes

  1. Cosmetic satisfaction

    Time frame: Post-surgery 1 month and 3 month

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

Sponsors and collaborators

Lead sponsor

CHA University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 15, 2013
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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