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The purpose of this study is to evaluate the impact of implementing different types of suturing materials and techniques of vaginal cuff closure in robotic assisted laparoscopic hysterectomy on cost, operative time and post operative surgical outcomes.
Robotic assisted laparoscopic surgery is the fastest growing new modality in gynecologic surgery. Surgeons are adapting it to perform both benign and oncologic gynecologic procedures. Therefore, the fastest growing robotic procedure in the united states is hysterectomy.
The literature in laparoscopic hysterectomy, both robotic and non-robotic, reports a complication of vaginal closure disruption after hysterectomy higher than with abdominal surgery. Reasons hypothesized for this phenomenon include colpotomy (vaginal incision) technique, vaginal closure technique, and types of suture. At present, no further follow up studies have been done to test some of these hypothesis. In light of the rapid adoption of this approach to hysterectomy, more data on this issue will help the physician in counseling patients regarding complications, as well as helping surgeons choose materials and techniques in their hysterectomies which will diminish the chance for this unfortunate complication, which causes pain, hospitalization and excess morbidity after the original surgery.
Additionally, a parallel development of newer suturing materials, the so-called "barbed" self-anchoring sutures, typically fabricated from monofilament materials, have been reported used in laparoscopic hysterectomies in case series. The relative contribution of theses newer materials to the rates of cuff disruption is unknown.
The protocol proposes testing the null hypothesis that different suture materials and methods of closure do not cause a significant difference in the rates of vaginal cuff disruption after robotic assisted laparoscopic total hysterectomy.
Study design is a prospective randomized controlled trial. Patients will be blindly randomized to one of the 3 closure techniques using 3 different materials. Technique and material by necessity can not be blinded to the surgeon. Otherwise, standard surgical technique will be used. Followup in 2 and 6 weeks for clinical assessment will be performed. To asses the long term of cuff disruption, a 12 month interview will be also conducted. Data points will include operative time for closure, postoperative pain at 2 and 6 weeks, postoperative pain with urination/voiding at 2 and 6 weeks, spotting, bleeding and /or frank vaginal disruption documented at 2 and 6 weeks, and pain and presence of dyspareunia at 12 months will be assessed.
Cost associated with cuff closure will be calculated by addition of OR time and material cost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-lock suture | Active Comparator | V-lock absorbable Wound Closure Device, by Covidien |
|
| Vicryl suture | Active Comparator | Vicryl suture by Ethicon |
|
| Lapra-Ty II | Active Comparator | Lapra-Ty II, Absorbable Suture Clip, by Ethicon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V-lock suture | Device |
| ||
| Vicryl Suture |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal cuff dehiscence | Postoperative inspection for vaginal cuff dehiscence | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Post-operative vaginal bleeding, bowel or urinary dysfunction | 6 weeks |
| Operative time costs | Measurement of operative time and determination of unit cost per surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Eisenstein, MD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21059487 | Background | AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011 Jan-Feb;18(1):1-3. doi: 10.1016/j.jmig.2010.10.001. Epub 2010 Nov 6. No abstract available. | |
| 18619922 | Background | Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10. |
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|
| Lapra-Ty II | Device |
|
| 1 year |
| Suturing material costs | Comparison of the amount and type of suture utilized per surgery | 1 year |
| Operative suturing time | Time to complete Vaginal cuff closure | During surgery |
| Post operative pain | Visual Analog Scale | 6 weeks |
| Vaginal bleeding/ spotting | Presence of postoperative vaginal bleeding | 12 months |
| Resumption of sexual activity | Time to resumption of intercourse | 12 months |
| Dyspareunia | Assessment of Painful Intercourse | 12 months |
| 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. |
| 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. |