Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

Brigham and Women's Hospital14 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uterine Prolapse

Interventions

Laparoscopic supracervical hysterectomy with sacropexyPROCEDURE

Will involve laparoscopic entry to the abdomen to remove the uterus and suspension of the cervix and vaginal cuff to the sacrum with mesh. We will allow surgeons to conduct the surgery as they have perfected it

Vaginal hysterectomy with uterosacral colposuspensionPROCEDURE

Will involve removing the uterus vaginally followed by suspending the vaginal cuff to the high (proximal) uterosacral ligaments bilaterally restoring the vagina to its normal axis.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Brigham And Women's Hospital

Boston, Massachusetts, United States

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

Absence of re-treatment for prolapse at 2 years

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?"

This is a question from the standardized questionnaire called Pelvic Floor Discomfort Inventory (PFDI).

Time frame: 24 months

Secondary Outcomes

Changes in POPQ measurements

Time frame: 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

EQ-5D assesses a patient's health that day PFDI- pelvic floor discomfort questions PFIQ - pelvic floor impact on daily activity questions SF-12 - general health/quality of life questions Standard Gamble Interview - an overall general health/quality of life questionnaire

Time frame: baseline, 3, 12, and 24 months

Change in patient reported sexual questionnaire, PISQ

PISQ - pelvic organ prolapse/urinary incontinence sexual questionnaire

Time frame: baseline, 3, 12 and 24 months

Frequencies of surgical and post-operative complications

Complications will be classified and reported, based on severity.

Time frame: up to 2 years post-operatively

Data from ClinicalTrials.gov

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