Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques

Study Overview
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Brief Summary
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The purpose of this study is to learn about the effect of different vaginal cuff closure techniques on pelvic support after laparoscopic hysterectomy and robotic assisted laparoscopic hysterectomy for benign gynecologic conditions.

Official Title
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Pelvic Floor Support After Laparoscopic Hysterectomy for Benign Conditions: A Randomized Controlled Trial Comparing Vaginal Cuff Closure Techniques

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Laparoscopic - Vaginal Cuff Closure
* Procedure: Vaginal- Vaginal Cuff Closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women over 18 years of age undergoing total laparoscopic hysterectomy and robotic assisted total laparoscopic hysterectomy for benign disease. Subjects must be able to self-consent. Department of Defense beneficiary Exclusion Criteria: Patients will be excluded if they undergo a concurrent procedure for prolapse. If the indication for the procedure is a malignancy. Those that plan to leave the area in less than 1 year will not be included. Pop-Q Point C of >-4

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic - Vaginal Cuff Closure<br> | Procedure: Laparoscopic - Vaginal Cuff Closure<br>* All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close laparoscopically using an 0-Barbed suture.<br>|
| Active Comparator: Vaginal - Vaginal Cuff Closure<br> | Procedure: Vaginal- Vaginal Cuff Closure<br>* All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close vaginally using an 0-Vicryl suture in a vertical fashion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic Organ Prolapse - Quantification Point C | The Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 6-8 weeks to see if prolapse is better using one method vs the other. | 6-8 weeks post op | 
| Pelvic Organ Prolapse - Quantification Point C | The Pelvic Organ Prolapse - Quantification system is a validated way to measure pelvic organ prolapse. The investigators will measure this post op at 1 year to see if prolapse is better using one method vs the other. | 1 year post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Cuff Dehiscence |  | 1 year | 
| Vaginal Cuff Abscess |  | 1 year | 
| Vaginal Cuff Cellulitis |  | 1 year | 
| Vaginal Cuff bleeding |  | 1 year |