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| ID | Type | Description | Link |
|---|---|---|---|
| 12-14 | Other Identifier | Baptist HealthCare IRB |
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| Name | Class |
|---|---|
| Methodist LeBonheur Hospital System | UNKNOWN |
| The West Clinic | UNKNOWN |
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This study is designed to determine if using the V-Loc Wound Closure System expedites operative time in robotic hysterectomy.
Currently both traditional continuous smooth suture and unidirectional barbed suture techniques are standard of care in robotic hysterectomy and the decision of which to use is at the discretion of the surgeon. By using unidirectional barbed suture in which no knot tying is required, wound closure time may be decreased resulting in decreased operative time. This study was created to compare vaginal cuff closure times using these two techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-Loc Vaginal Cuff Closure | Experimental | Patients in this arm will receive vaginal cuff closure with unidirectional barbed suture at time of their robotic hysterectomy. |
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| Vicryl Vaginal Cuff Closure | Active Comparator | Patients enrolled in this arm will have their vaginal cuff closed with polyglactin 910 (Vicryl) at the time of their robotic hysterectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unidirectional Barbed Suture (V-Loc) | Device | Patients enrolled in the Unidirectional Barbed Suture arm will have their vaginal cuff closed using this device during their robotic hysterectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Cuff Closure Time | Vaginal cuff closure time will be timed at time of robotic hysterectomy. | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Cuff Dehiscence | Patients will be evaluated post operatively by physical examination to determine if a vaginal cuff dehiscence has occurred and will be again screened by phone 3 months post operatively. | Post Operatively (3 months) |
| Vaginal Cuff Evisceration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Todd Tillmanns, MD | University of Tennessee, The West Clinic | Principal Investigator |
| Adam Mabe, MD | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist University Hospital | Memphis | Tennessee | 38103 | United States | ||
| The West Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19935045 | Background | Bradshaw AD, Advincula AP. Incidence and characteristics of patients with vaginal cuff dehiscence after robotic procedures. Obstet Gynecol. 2009 Dec;114(6):1372. doi: 10.1097/AOG.0b013e3181c3f60f. No abstract available. | |
| 21354068 | Background | Siedhoff MT, Yunker AC, Steege JF. Decreased incidence of vaginal cuff dehiscence after laparoscopic closure with bidirectional barbed suture. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):218-23. doi: 10.1016/j.jmig.2011.01.002. |
| Label | URL |
|---|---|
| V-Loc Wound Closure Device Device Information | View source |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| polyglactin 910 (Vicryl) | Device | Patients in the Smooth Suture arm will have their vaginal cuff closed with this device during their robotic hysterectomy. |
|
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Patients will be evaluated post operatively by physical examination to determine if a vaginal cuff evisceration has occurred and will be again screened by phone 3 months post operatively. |
| Post Operatively (3 months) |
| Vaginal Cuff Granulation Tissue Formation | Patients will be evaluated post operatively by physical examination to determine if a vaginal cuff granulation tissue formation has occurred and will be again screened by phone 3 months post operatively. | Post Operatively (3 months) |
| Memphis |
| Tennessee |
| 38120 |
| United States |
| 21333192 | Background | Einarsson JI, Vellinga TT, Twijnstra AR, Chavan NR, Suzuki Y, Greenberg JA. Bidirectional barbed suture: an evaluation of safety and clinical outcomes. JSLS. 2010 Jul-Sep;14(3):381-5. doi: 10.4293/108680810X12924466007566. |
| 21364859 | Background | Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91. |