NCT02696239

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
Last Updated

December 6, 2023

Status Verified

February 1, 2016

Enrollment Period

5.4 years

First QC Date

February 21, 2016

Last Update Submit

November 30, 2023

Conditions

Complications of Medical Care

Keywords

vaginal cuff closureRobotic Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Vaginal cuff dehiscence

    Postoperative inspection for vaginal cuff dehiscence

    12 months

Secondary Outcomes (8)

  • Complications

    6 weeks

  • Operative time costs

    1 year

  • Suturing material costs

    1 year

  • Operative suturing time

    During surgery

  • Post operative pain

    6 weeks

  • +3 more secondary outcomes

Study Arms (3)

V-lock suture

ACTIVE COMPARATOR

V-lock absorbable Wound Closure Device, by Covidien

Device: V-lock suture

Vicryl suture

ACTIVE COMPARATOR

Vicryl suture by Ethicon

Device: Vicryl Suture

Lapra-Ty II

ACTIVE COMPARATOR

Lapra-Ty II, Absorbable Suture Clip, by Ethicon

Device: Lapra-Ty II

Interventions

V-lock sutureDEVICE
V-lock suture
Vicryl SutureDEVICE
Vicryl suture
Lapra-Ty IIDEVICE
Lapra-Ty II

Eligibility Criteria

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

You may qualify if:

  • Women scheduled for robotic assisted laparoscopic hysterectomy

You may not qualify if:

  • Patients who will not consent.
  • Hysterectomy due to malignant conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (4)

  • 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.

    PMID: 21059487BACKGROUND

  • 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.

    PMID: 18619922BACKGROUND

  • 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

  • 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

Study Officials

  • David Eisenstein, MD

    Henry Ford Health System

    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
SPONSOR

Study Record Dates

First Submitted

February 21, 2016

First Posted

March 2, 2016

Study Start

September 1, 2010

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

December 6, 2023

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)