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

Walter Reed National Military Medical Center

Status: Terminated

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Vaginal- Vaginal Cuff Closure; Procedure: Laparoscopic - Vaginal Cuff Closure

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03753516

WRNMMC-2017-0055

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Laparoscopic - Vaginal Cuff Closure

Active Comparator group

Treatment:

Procedure: Laparoscopic - Vaginal Cuff Closure

Vaginal - Vaginal Cuff Closure

Active Comparator group

Treatment:

Procedure: Vaginal- Vaginal Cuff Closure