Clinical trial NCT01984632: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Myoma
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Suturing time
timeFrame: Intra-operative
Secondary outcomes:
measure: Cosmetic satisfaction
timeFrame: Post-surgery 1 month and 3 month
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
city: Seoul
country: Korea, Republic of
facility: CHA Gangnam Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea
name: Taejong Song, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.