Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy
NCT ID: NCT01814579
Last Updated: 2013-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2012-07-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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V-Loc Vaginal Cuff Closure
Patients in this arm will receive vaginal cuff closure with unidirectional barbed suture at time of their robotic hysterectomy.
Unidirectional Barbed Suture (V-Loc)
Patients enrolled in the Unidirectional Barbed Suture arm will have their vaginal cuff closed using this device during their robotic hysterectomy.
Vicryl Vaginal Cuff Closure
Patients enrolled in this arm will have their vaginal cuff closed with polyglactin 910 (Vicryl) at the time of their robotic hysterectomy.
polyglactin 910 (Vicryl)
Patients in the Smooth Suture arm will have their vaginal cuff closed with this device during their robotic hysterectomy.
Interventions
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Unidirectional Barbed Suture (V-Loc)
Patients enrolled in the Unidirectional Barbed Suture arm will have their vaginal cuff closed using this device during their robotic hysterectomy.
polyglactin 910 (Vicryl)
Patients in the Smooth Suture arm will have their vaginal cuff closed with this device during their robotic hysterectomy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females age 18+
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Methodist LeBonheur Hospital System
UNKNOWN
The West Clinic
UNKNOWN
University of Tennessee
OTHER
Responsible Party
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Adam Mabe
Resident Physician
Principal Investigators
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Todd Tillmanns, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee, The West Clinic
Adam Mabe, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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Methodist University Hospital
Memphis, Tennessee, United States
The West Clinic
Memphis, Tennessee, United States
Countries
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References
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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.
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.
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.
Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91.
Related Links
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V-Loc Wound Closure Device Device Information
Other Identifiers
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12-14
Identifier Type: OTHER
Identifier Source: secondary_id
11-01423-FB
Identifier Type: -
Identifier Source: org_study_id
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