NCT02117492

Brief Summary

The purpose of this study is to evaluate the possible impacts of two techniques of vaginal cuff closure during robotic hysterectomy. We aim to compare vertical vs horizontal vaginal cuff closure and the impact that these techniques have on vaginal length, sexual function, and overall complication rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

3 years

First QC Date

April 16, 2014

Last Update Submit

September 19, 2017

Conditions

Hysterectomy

Keywords

hysterectomyvaginal cuff

Outcome Measures

Primary Outcomes (1)

  • Vaginal Length

    The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, at 4-6 weeks postoperatively.

    up to 4-6 weeks post-operative

Secondary Outcomes (1)

  • Sexual Function

    Pre-operative, 6 and 12 months post-operativey

Other Outcomes (1)

  • Complication Rates

    up to 12 months post-operativey

Study Arms (2)

Vertical Cuff

EXPERIMENTAL

Vaginal cuff closure will be done vertically.

Procedure: Cuff Closure

Horizontal Cuff

EXPERIMENTAL

Vaginal cuff closure will be done horizontally.

Procedure: Cuff Closure

Interventions

Cuff ClosurePROCEDURE

Closure of the vaginal cuff following hysterectomy.

Horizontal CuffVertical Cuff

Eligibility Criteria

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

You may qualify if:

  • \. Female premenopausal patients undergoing robot assisted total laparoscopic hysterectomy

You may not qualify if:

  • Adults unable to consent
  • Children under the age of 18
  • Pregnant women
  • Prisoners
  • Post-menopausal women
  • Women with the known preoperative need for bowel or genitourinary surgery at the time of hysterectomy
  • Patients unable to consent to the procedure in the English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Study Officials

  • Timothy A Deimling, MD, MS

    Milton S. Hershey Medical Center

    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
Minimally Invastive GYN Surgery

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

September 20, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)