A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure

September 19, 2017 updated by: Timothy A Deimling, Milton S. Hershey Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vertical Cuff
Vaginal cuff closure will be done vertically.
Procedure: Cuff Closure
Closure of the vaginal cuff following hysterectomy.
EXPERIMENTAL: Horizontal Cuff
Vaginal cuff closure will be done horizontally.
Procedure: Cuff Closure
Closure of the vaginal cuff following hysterectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal Length
Time Frame: up to 4-6 weeks post-operative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual Function
Time Frame: Pre-operative, 6 and 12 months post-operativey
Secondary outcomes will include sexual function measured with FSFI preoperatively and at 6 months and 12 months post operatively.
Pre-operative, 6 and 12 months post-operativey

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication Rates
Time Frame: up to 12 months post-operativey
Overall complication rates will be monitored.
up to 12 months post-operativey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Timothy A Deimling, MD, MS, Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2014

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (ESTIMATE)

April 21, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 20, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 00000143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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