Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse
Status unconfirmed · Not applicable
Conditions studied: Vaginal Vault Prolapse, Post-Hysterectomy Vaginal Vault Prolapse, Prolapse, Vaginal
In brief
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.
Key facts
- Study ID
- NCT04172896
- Run by
- The Methodist Hospital Research Institute
- People needed
- 34
- Starts
- 2019-11-01
- Expected to finish
- 2021-09-01
- Last updated by the study team
- 2019-11-21
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Non-English speaking or not able to provide informed consent
- Combined surgical cases with other surgical specialties
- Women unable to follow up postoperatively
Where it is running
- Houston Methodist Hospital — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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