Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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-Locâ„¢ suture material (study group). The other group will receive conventional multi-port laparoscopic myomectomy using V-Locâ„¢ suture material (control group). The investigators will collect information on suturing time and complications related to surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-port laparoscopic myomectomy | Experimental | We will use barbed suture (V-Loc) under intervention of single-port laparoscopic myomectomy |
|
| Multi-port laparoscopic myomectomy | Active Comparator | We will use barbed suture(V-Loc) under intervention of multi-port laparoscopic myomectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-port laparoscopic myomectomy | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Suturing time | the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy | Intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic satisfaction | We will compare patient's cosmetic satisfaction through self-reported questionnaire (Body image Questionnaire). | Post-surgery 1 month and 3 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Taejong Song, MD | CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Health Insurance Service Ilsan Hospital | Goyang | South Korea | ||||
| CHA Gangnam Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26263079 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Multi-port laparoscopic myomectomy | Procedure | 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). |
|
| Seoul |
| South Korea |
| Kangbuk Samsung Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |