Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
80 participants
INTERVENTIONAL
2013-11-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Single-port laparoscopic myomectomy
We will use barbed suture (V-Loc) under intervention of single-port laparoscopic myomectomy
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
We will use barbed suture(V-Loc) under intervention of multi-port laparoscopic myomectomy.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
55 Years
FEMALE
No
Sponsors
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CHA University
OTHER
Responsible Party
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Taejong Song
Professor
Principal Investigators
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Taejong Song, MD
Role: PRINCIPAL_INVESTIGATOR
CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea
Locations
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National Health Insurance Service Ilsan Hospital
Goyang, , South Korea
CHA Gangnam Medical Center
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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MYO04
Identifier Type: -
Identifier Source: org_study_id