Randomized Trial Comparing Vaginal Hysterectomy to Laparoscopic Supracervical Hysterectomy With Vault Suspension for Symptomatic Uterine Prolapse
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Whether or not POPQ points AA, BA, Ap, or Bp are at less than 0 cm from the hymen OR whether point C descends less than 1/3 of the total vaginal length (TVL)
Study Overview
Brief Summary
Investigators intend to conduct a prospective randomized trial to compare vaginal hysterectomy with uterosacral colposuspension to laparoscopic supracervical hysterectomy with sacrocervicopexy. Both surgeries are minimally-invasive surgical standards of care for uterine prolapse repair. Nobody knows if one procedure is superior to the other, as they have not been compared directly. The investigators hypothesize that there is no difference in objective, subjective, or cost-effectiveness between the two procedures for up to two years after surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with primary symptomatic uterine prolapse
- •≥ 18 years of age
- •Considering pelvic reconstructive surgery
Exclusion Criteria
- •Unwillingness to be randomized to one of two surgical approaches
- •Pregnant or planning to maintain their future fertility
- •Unable to have general anesthesia
- •Currently undergoing chemotherapy OR has current or history of pelvic radiation
- •Previous adverse reaction to synthetic mesh
- •Recent history of abnormal paps (past 10 years)
- •Cervical or uterine cancers
- •Previous hysterectomy
- •Previous central vault or uterine prolapse repair
- •Uterus ≥ 14 weeks size
- •Uterine cancer
- •History of significant pelvic adhesive disease
- •Elongated cervix (length D to C > 6cm)
- •Fibroid ≥ 7cm
- •Post menopausal with enlarged uterus
Arms & Interventions
Laparoscopic Repair
Laparoscopic supracervical hysterectomy with sacropexy
Intervention: Laparoscopic supracervical hysterectomy with sacropexy (Procedure)
Vaginal Repair
Vaginal hysterectomy with uterosacral colposuspension
Intervention: Vaginal hysterectomy with uterosacral colposuspension (Procedure)
Outcomes
Primary Outcomes
Whether or not POPQ points AA, BA, Ap, or Bp are at less than 0 cm from the hymen OR whether point C descends less than 1/3 of the total vaginal length (TVL)
Time Frame: 24 months
A negative response to "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?"
Time Frame: 24 months
This is a question from the standardized questionnaire called Pelvic Floor Discomfort Inventory (PFDI).
Absence of re-treatment for prolapse at 2 years
Time Frame: 24 months
Secondary Outcomes
- Change in patient reported sexual questionnaire, PISQ(baseline, 3, 12 and 24 months)
- Frequencies of surgical and post-operative complications(up to 2 years post-operatively)
- Changes in POPQ measurements(baseline, 6 week, and 3, 12, and 24 months)
- Changes in Patient-reported quality of life scores from the EQ-5D, PFDI, PFIQ, SF-12, Standard Gamble Interview, Pain Scale and Activity Assessment(baseline, 3, 12, and 24 months)
Investigators
Vatche Arakel Minassian
Director of Urogynecology
Brigham and Women's Hospital