Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 6:59 AM
Study NCT ID:
NCT01984632
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2013-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Barbed Suture in Single-port Laparoscopic Myomectomy
Sponsor:
CHA University
Organization:
Study Overview
Official Title:
Single-port Laparoscopic Myomectomy Using Barbed Suture Versus Multi-port One: a Multi-center Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: