Barbed Suture in Single-port Laparoscopic Myomectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by CHA University
Sponsor:
Information provided by (Responsible Party):
Taejong Song, CHA University
ClinicalTrials.gov Identifier:
NCT01984632
First received: November 3, 2013
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Uterine Myoma
Procedure: Single-port laparoscopic myomectomy
Procedure: Multi-port laparoscopic myomectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single-port Laparoscopic Myomectomy Using Barbed Suture Versus Multi-port One: a Multi-center Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by CHA University:

Primary Outcome Measures:
  • Suturing time [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
    the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy


Secondary Outcome Measures:
  • Cosmetic satisfaction [ Time Frame: Post-surgery 1 month and 3 month ] [ Designated as safety issue: No ]
    We will compare patient's cosmetic satisfaction through self-reported questionnaire (Body image Questionnaire).


Estimated Enrollment: 80
Study Start Date: November 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984632

Contacts
Contact: Taejong Song +82-10-4035-8405 taejong.song@gmail.com

Locations
Korea, Republic of
National Health Insurance Service Ilsan Hospital Recruiting
Goyang, Korea, Republic of
Contact: San-Hui Lee, Professor    +82-10-9948-4459    sanaram@naver.com   
Principal Investigator: San-Hui Lee, Professor         
CHA Gangnam Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Taejong Song, Professor    +82-10-4035-8405    taejong.song@gmail.com   
Principal Investigator: Taejong Song, Professor         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Tae-Joong Kim, Professor    +82-10-9933-3547    tj28.kim@gmail.com   
Principal Investigator: Tae-Joong Kim, Professor         
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of
Contact: Woo Young Kim, Professor    +82-10-5343-3481    obgykim@gmail.com   
Principal Investigator: Woo Young Kim, Professor         
Sponsors and Collaborators
CHA University
Investigators
Principal Investigator: Taejong Song, MD CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea
  More Information

No publications provided

Responsible Party: Taejong Song, Professor, CHA University
ClinicalTrials.gov Identifier: NCT01984632     History of Changes
Other Study ID Numbers: MYO04
Study First Received: November 3, 2013
Last Updated: November 21, 2013
Health Authority: South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Myoma
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 29, 2014