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

NCT04172896 | Unknown

• 1 other identifier: Pro00022633
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

Pelvic Reconstructive Surgery; Prolapse Surgery

Outcome Measures

Primary Outcomes (1)

• Operative time (minutes)

  Minutes from surgical incision time to surgery end time

  Day of surgery

Secondary Outcomes (16)

• Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 6 week postoperative visit

  6 week

• Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 6 month postoperative visit

  6 month

• Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 12 month postoperative visit

  12 month

• Hospital length of stay (hours)

  Up to 7 days

• Surgical encounter total direct costs ($)

  Up to 7 days

Study Arms (2)

Intraperitoneal Group

ACTIVE COMPARATOR

Vaginal intraperitoneal uterosacral ligament suspension group

Procedure: Intraperitoneal Uterosacral Ligament Suspension

Extraperitoneal Group

ACTIVE COMPARATOR

Vaginal extraperitoneal uterosacral ligament suspension group

Procedure: Extraperitoneal Uterosacral Ligament Suspension

Interventions

Intraperitoneal Uterosacral Ligament Suspension 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).

Intraperitoneal Group

Extraperitoneal Uterosacral Ligament Suspension 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).

Extraperitoneal Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patients with post-hysterectomy vaginal vault prolapse
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse; Uterine Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Tristi Muir, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Danny Mounir, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danny Mounir, MD

CONTACT

713-363-7592; dmmounir@houstonmethodist.org

Nickie Griffin, BS

CONTACT

713-363-7592; ngriffin@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow

Model Details: This is a two-arm parallel design. Participants will be randomly assigned to either vaginal intraperitoneal or extraperitoneal uterosacral ligament suspension.

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 21, 2019
• Study Start: November 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)