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

Not Applicable

Terminated

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Vaginal- Vaginal Cuff Closure; Procedure: Laparoscopic - Vaginal Cuff Closure

• Registration Number: NCT03753516
• Lead Sponsor: Walter Reed National Military Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-27
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal - Vaginal Cuff Closure	Vaginal- Vaginal Cuff Closure	-
Laparoscopic - Vaginal Cuff Closure	Laparoscopic - Vaginal Cuff Closure	-

Primary Outcome Measures

Name	Time	Method
Pelvic Organ Prolapse - Quantification Point C	1 year post op	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.

Secondary Outcome Measures

Name	Time	Method
Vaginal Cuff Abscess	1 year
Vaginal Cuff Dehiscence	1 year
Vaginal Cuff bleeding	1 year
Vaginal Cuff Cellulitis	1 year

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States