Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy

NCT ID: NCT01814579

Last Updated: 2013-03-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-08-31

Brief Summary

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This study is designed to determine if using the V-Loc Wound Closure System expedites operative time in robotic hysterectomy.

Detailed Description

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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.

Conditions

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Disease (or Disorder); Gynecological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Group Type EXPERIMENTAL

Unidirectional Barbed Suture (V-Loc)

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

polyglactin 910 (Vicryl)

Intervention Type DEVICE

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.

Intervention Type DEVICE

polyglactin 910 (Vicryl)

Patients in the Smooth Suture arm will have their vaginal cuff closed with this device during their robotic hysterectomy.

Intervention Type DEVICE

Other Intervention Names

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V-Loc Wound Closure System Vicryl

Eligibility Criteria

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Inclusion Criteria

* Women being scheduled to have a robotic hysterectomy for benign or malignant disease by the West Clinic Gynecology-Oncology Physicians
* Females age 18+

Exclusion Criteria

* Patients receiving ongoing radiation therapy to the pelvis
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Methodist LeBonheur Hospital System

UNKNOWN

Sponsor Role collaborator

The West Clinic

UNKNOWN

Sponsor Role collaborator

University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Adam Mabe

Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

The West Clinic

Memphis, Tennessee, United States

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 19935045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21354068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21333192 (View on PubMed)

Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91.

Reference Type BACKGROUND
PMID: 21364859 (View on PubMed)

Related Links

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http://www.covidien.com/vloc/pages.aspx

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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