Clinical trial NCT04172896: Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse
Official title: Comparison of Vaginal Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Vault Prolapse
Post-Hysterectomy Vaginal Vault Prolapse
Prolapse, Vaginal
Keywords: Pelvic Reconstructive Surgery
Prolapse Surgery
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm parallel design. Participants will be randomly assigned to either vaginal intraperitoneal or extraperitoneal uterosacral ligament suspension.
Primary purpose: TREATMENT

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.

Detailed description: This is a single-center, randomized, single-blind surgical trial of women with post-hysterectomy vaginal vault prolapse desiring surgical treatment. The purpose of this study is to compare outcomes of vaginal intraperitoneal uterosacral ligament suspensions and vaginal extraperitoneal uterosacral ligament suspensions for the treatment of post-hysterectomy vaginal vault prolapse. The primary objective will be to compare operative time between the two approaches. Secondary objectives of the trial will be to compare hospital stay, cost, surgical success, and other perioperative outcomes between the two approaches through 12 months using assessments at six weeks, six months, and twelve months.

The study will include subjects with stage 1-4 pelvic organ prolapse and descent of the vaginal apex at least ½ way into vaginal canal (defined as POPQ Point C ≥ -TVL/2) that desire vaginal surgical management for post-hysterectomy vaginal vault prolapse. Subjects enrolled into the trial will be randomized to either vaginal intraperitoneal or extraperitoneal uterosacral ligament suspension with a 1:1 allocation using a computer-generated randomization schedule. Patients will be blinded to their allocation. Patients in both groups will receive the same standard of care for vaginal procedures as it currently exists in out practice. This involves the standard anesthetics and opioid medications intraoperatively. Randomization will be revealed to the surgeons in the operating room once the patient is under general anesthesia.

Intraoperative data to be collected will include, operative time (minutes from surgical incision time to surgery end time), estimated blood loss (ml), intraoperative complications, and concurrent surgical procedures.

Preoperative and postoperative clinical measures to be collected will include POPQ examination points and scores from three validated questionnaires (Pelvic Floor Disability Index (PFDI-20) questionnaire, Pelvic Floor Impact Questionnaires (PFIQ-7) and the Pelvic and Incontinence Sexual Questionnaire (PISQ-12)). Postoperative clinical measures will be collected at six week, six month, and twelve month post-operative visits.

Surgical success or failure will be evaluated as a dichotomous composite outcome(objective measures (POPQ examination points) and subjective measures(validated questionnaires) at six week, six month, and twelve month post-operative visits.

Eligibility criteria: 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

Primary outcomes:
measure: Operative time (minutes)
timeFrame: Day of surgery
Secondary outcomes:
measure: Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 6 week postoperative visit
timeFrame: 6 week
measure: Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 6 month postoperative visit
timeFrame: 6 month
measure: Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 12 month postoperative visit
timeFrame: 12 month
measure: Hospital length of stay (hours)
timeFrame: Up to 7 days
measure: Surgical encounter total direct costs ($)
timeFrame: Up to 7 days
measure: Estimated blood loss (ml)
timeFrame: Day of surgery
measure: Frequency of perioperative complications (%)
timeFrame: 6 week
measure: Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 6 week postoperative visit
timeFrame: 6 week
measure: Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 6 month postoperative visit
timeFrame: 6 month
measure: Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 12 month postoperative visit
timeFrame: 12 month
measure: Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 6 week postoperative visit
timeFrame: 6 week
measure: Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 6 month postoperative visit
timeFrame: 6 month
measure: Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 12 month postoperative visit
timeFrame: 12 month
measure: Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) score at the 6 month postoperative visit
timeFrame: 6 month
measure: Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) score at the 12 month postoperative visit
timeFrame: 12 month
measure: Mean postoperative numerical rating scale (NRS) score of pain intensity at 1 week after surgery
timeFrame: 1 week
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Tristi Muir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Methodist Hospital Research Institute
name: Danny Mounir, MD
role: PRINCIPAL_INVESTIGATOR
References: