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A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure

NCT ID: NCT02117492

Last Updated: 2017-09-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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A Validated questionnaire the Female Sexual Function Index (FSFI) and total vaginal lengths will be used to evaluate patients pre-operatively, at 4-6 weeks post-operatively, and 6 months post operatively. The FSFI will also be sent to the patient 12 months post operatively. These data will be used to assess sexual function and total vaginal length in patients undergoing minimally invasive hysterectomy. The study endpoint will occur after the 12 month follow-up questionnaire. Additionally, all complications following surgery will be tracked over the study period for comparison.

Conditions

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Hysterectomy

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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Vertical Cuff

Vaginal cuff closure will be done vertically.

Group Type EXPERIMENTAL

Cuff Closure

Intervention Type PROCEDURE

Closure of the vaginal cuff following hysterectomy.

Horizontal Cuff

Vaginal cuff closure will be done horizontally.

Group Type EXPERIMENTAL

Cuff Closure

Intervention Type PROCEDURE

Closure of the vaginal cuff following hysterectomy.

Interventions

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Cuff Closure

Closure of the vaginal cuff following hysterectomy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Adults unable to consent
2. Children under the age of 18
3. Pregnant women
4. Prisoners
5. Post-menopausal women
6. Women with the known preoperative need for bowel or genitourinary surgery at the time of hysterectomy
7. Patients unable to consent to the procedure in the English language
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Timothy A Deimling

Minimally Invastive GYN Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timothy A Deimling, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

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Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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00000143

Identifier Type: -

Identifier Source: org_study_id