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Completed

NCT Number: NCT02117492

A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure

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.

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Key information

Conditions

Hysterectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female premenopausal patients undergoing robot assisted total laparoscopic hysterectomy

Exclusion criteria

  • 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

Treatment and study plan

Cuff Closure

Procedure

Closure of the vaginal cuff following hysterectomy.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. Complication Rates

    Time frame: up to 12 months post-operativey

    Overall complication rates will be monitored.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 21, 2014
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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