A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure

Not Applicable

Completed

• Conditions: Hysterectomy
• Interventions: Procedure: Cuff Closure

• Registration Number: NCT02117492
• Lead Sponsor: Milton S. Hershey Medical Center

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.

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 Timeline

• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-21
• Study Start: 2014-05
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vertical Cuff	Cuff Closure	Vaginal cuff closure will be done vertically.
Horizontal Cuff	Cuff Closure	Vaginal cuff closure will be done horizontally.

Primary Outcome Measures

Name	Time	Method
Vaginal Length	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 Outcome Measures

Name	Time	Method
Sexual Function	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.

Trial Locations

Locations (1)

Penn State Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States