Recruiting

Uterosacral Suspension

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT04172896

Conditions

Vaginal Vault Prolapse

Post-Hysterectomy Vaginal Vault Prolapse

Prolapse, Vaginal

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intraperitoneal Uterosacral Ligament Suspension

Extraperitoneal Uterosacral Ligament Suspension

Study Details

Brief 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

Study ID

NCT04172896

Start date

Nov 1, 2019

Status verified date

Nov, 2019

Completion date

Sep, 2021

Anticipated

Primary completion date

Sep, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women who are 18 years of age or greater
  • English speaking
  • Stage 1 or greater post-hysterectomy vaginal vault prolapse
  • Descent of vaginal apex at least ½ way into vaginal canal (defined as POPQ Point C ≥ -TVL/2)
  • Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure

Exclusion Criteria:

  • Non-English speaking or not able to provide informed consent
  • Combined surgical cases with other surgical specialties
  • Women unable to follow up postoperatively

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intraperitoneal Group

Vaginal intraperitoneal uterosacral ligament suspension group

active comparator: Extraperitoneal Group

Vaginal extraperitoneal uterosacral ligament suspension group

Interventions

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).

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).

Primary outcome measure

  • Operative time (minutes) [ Time Frame: Day of surgery ]

Central Contacts and Locations

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Nov 21, 2019

Last verified

Nov, 2019

Keywords

  • Pelvic Reconstructive Surgery
  • Prolapse Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2019-11-21.