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

NCT ID: NCT04172896

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-09-30

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.

Conditions

Vaginal Vault Prolapse; Post-Hysterectomy Vaginal Vault Prolapse; Prolapse, Vaginal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intraperitoneal Group

Vaginal intraperitoneal uterosacral ligament suspension group

Group Type: ACTIVE_COMPARATOR

Intraperitoneal Uterosacral Ligament Suspension

Intervention Type: PROCEDURE

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 Group

Vaginal extraperitoneal uterosacral ligament suspension group

Group Type: ACTIVE_COMPARATOR

Extraperitoneal Uterosacral Ligament Suspension

Intervention Type: PROCEDURE

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).

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).

Intervention Type: 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).

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Danny Mounir

Clinical Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tristi Muir, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Danny Mounir, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Houston Methodist Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Danny Mounir, MD

Role: CONTACT

dmmounir@houstonmethodist.org

713-363-7592

Nickie Griffin, BS

Role: CONTACT

ngriffin@houstonmethodist.org

713-363-7592

Facility Contacts

Danny Mounir, MD

Role: primary

dmmounir@houstonmethodist.org

337-298-0964

Other Identifiers

Pro00022633

Identifier Type: -

Identifier Source: org_study_id