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

Walter Reed National Military Medical Center58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pelvic Organ Prolapse

Interventions

Laparoscopic - Vaginal Cuff ClosurePROCEDURE

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.

Vaginal- Vaginal Cuff ClosurePROCEDURE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 year post op

Secondary Outcomes

Vaginal Cuff Dehiscence

Time frame: 1 year

Vaginal Cuff Abscess

Time frame: 1 year

Vaginal Cuff Cellulitis

Time frame: 1 year

Vaginal Cuff bleeding

Time frame: 1 year

Data from ClinicalTrials.gov

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