MedTrace Logo

Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse

NCT04172896 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-11-21

No results posted yet for this study

Summary

Post-hysterectomy vaginal vault prolapse is a common pelvic floor disorder described as descent of the vaginal apex after hysterectomy. The incidence of post-hysterectomy vault prolapse has been reported to follow 11.6% of hysterectomies performed for prolapse and 1.8% for other benign diseases. The majority of surgical repairs to correct post-hysterectomy vault prolapse are approached via a transvaginal route. A common transvaginal procedure to correct vaginal vault prolapse is the uterosacral ligament suspension. Traditionally, the uterosacral ligaments have been accessed intraperitoneally to perform the vaginal suspension. More recently, an extraperitoneal approach has been utilized with good results. There is limited evidence comparing the the two approaches. Thus, the objectives of this study are to compare compare operative time, hospital stay, cost, surgical success, and other perioperative outcomes between the two approaches.

Conditions

  • Vaginal Vault Prolapse
  • Post-Hysterectomy Vaginal Vault Prolapse
  • Prolapse, Vaginal

Interventions

PROCEDURE

Intraperitoneal Uterosacral Ligament Suspension

Vaginal intraperitoneal uterosacral ligament suspension performed by transfixing the ligament, intraperitoneally, in the intermediate portion (at the level of or above ischial spine plane) with three delayed absorbable 0 sutures, performed bilaterally (three sutures per side; six sutures total).

PROCEDURE

Extraperitoneal Uterosacral Ligament Suspension

Vaginal extraperitoneal uterosacral ligament suspension performed by transfixing the ligament, extraperitoneally, in the intermediate portion (at the level of or above ischial spine plane) using a suture capturing device with two delayed absorbable 0 sutures, performed bilaterally (two sutures per side; four sutures total).

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Tristi Muir, MD · The Methodist Hospital Research Institute

  • Danny Mounir, MD · The Methodist Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-09-30
Completion
2021-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04172896 on ClinicalTrials.gov