A Phase 3 interventional study of Single-port laparoscopic myomectomy and Multi-port laparoscopic myomectomy in Uterine Myoma, sponsored by CHA University. Completed at 4 sites in Korea, Republic of. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-07-31.
Sponsored by CHA University · Phase 3, Interventional, and Treatment
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.
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 80 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →CHA University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
We will use barbed suture (V-Loc) under intervention of single-port laparoscopic myomectomy
Procedure: Single-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).
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).
Suturing time
the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy
Time frame: Intra-operative
Cosmetic satisfaction
We will compare patient's cosmetic satisfaction through self-reported questionnaire (Body image Questionnaire).
Time frame: Post-surgery 1 month and 3 month
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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CHA University