A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure

Study Overview
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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.

Official Title
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A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure

Conditions
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Hysterectomy

Intervention / Treatment
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* Procedure: Cuff Closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vertical Cuff<br>Vaginal cuff closure will be done vertically. | Procedure: Cuff Closure<br>* Closure of the vaginal cuff following hysterectomy.<br>|
| Experimental: Horizontal Cuff<br>Vaginal cuff closure will be done horizontally. | Procedure: Cuff Closure<br>* Closure of the vaginal cuff following hysterectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Function | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hysterectomy, vaginal cuff