NCT01814579

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 26, 2013

Status Verified

March 1, 2013

Enrollment Period

10 months

First QC Date

March 16, 2013

Last Update Submit

March 25, 2013

Conditions

Disease (or Disorder); Gynecological

Keywords

vaginalcuffrobotichysterectomyvlocv-locvicrylunidirectionalbarbedsuture

Outcome Measures

Primary Outcomes (1)

  • Vaginal Cuff Closure Time

    Vaginal cuff closure time will be timed at time of robotic hysterectomy.

    At time of surgery

Secondary Outcomes (3)

  • Vaginal Cuff Dehiscence

    Post Operatively (3 months)

  • Vaginal Cuff Evisceration

    Post Operatively (3 months)

  • Vaginal Cuff Granulation Tissue Formation

    Post Operatively (3 months)

Study Arms (2)

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.

Device: Unidirectional Barbed Suture (V-Loc)

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.

Device: polyglactin 910 (Vicryl)

Interventions

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.

Also known as: V-Loc Wound Closure System
V-Loc Vaginal Cuff Closure
polyglactin 910 (Vicryl)DEVICE

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

Also known as: Vicryl
Vicryl Vaginal Cuff Closure

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients receiving ongoing radiation therapy to the pelvis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Methodist University Hospital

Memphis, Tennessee, 38103, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

Related Publications (4)

  • 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.

    PMID: 19935045BACKGROUND

  • 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.

    PMID: 21354068BACKGROUND

  • 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.

    PMID: 21333192BACKGROUND

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

    PMID: 21364859BACKGROUND

Related Links

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Todd Tillmanns, MD

    University of Tennessee, The West Clinic

    PRINCIPAL INVESTIGATOR

  • Adam Mabe, MD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

March 16, 2013

First Posted

March 20, 2013

Study Start

July 1, 2012

Primary Completion

May 1, 2013

Study Completion

August 1, 2013

Last Updated

March 26, 2013

Record last verified: 2013-03

Locations

US(2)