Clinical trial · Interventional
Barbed Suture in Single-port Laparoscopic Myomectomy
Single-port Laparoscopic Myomectomy Using Barbed Suture Versus Multi-port One: a Multi-center Randomized Controlled Trial
NCT01984632CI-TRIAL-00018733completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Myoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-port laparoscopic myomectomy | Procedure | — | UNRESOLVED |
| Single-port laparoscopic myomectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single-port laparoscopic myomectomy
- description
- We will use barbed suture (V-Loc) under intervention of single-port laparoscopic myomectomy
- interventionNames
- Procedure: Single-port laparoscopic myomectomy
- type
- ACTIVE_COMPARATOR
- label
- Multi-port laparoscopic myomectomy
- description
- We will use barbed suture(V-Loc) under intervention of multi-port laparoscopic myomectomy.
- interventionNames
- Procedure: Multi-port laparoscopic myomectomy
Primary outcomes (1)
- measure
- Suturing time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSong 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. PMID 26263079