Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

Not Applicable

Terminated

• Conditions: Uterine Prolapse
• Interventions: Procedure: Vaginal hysterectomy with uterosacral colposuspension; Procedure: Laparoscopic supracervical hysterectomy with sacropexy

• Registration Number: NCT01594372
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-09
• Study Start: 2013-01
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal Repair	Vaginal hysterectomy with uterosacral colposuspension	Vaginal hysterectomy with uterosacral colposuspension
Laparoscopic Repair	Laparoscopic supracervical hysterectomy with sacropexy	Laparoscopic supracervical hysterectomy with sacropexy

Primary Outcome Measures

Name	Time	Method
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)	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?"	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	24 months

Secondary Outcome Measures

Name	Time	Method
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	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
Change in patient reported sexual questionnaire, PISQ	baseline, 3, 12 and 24 months	PISQ - pelvic organ prolapse/urinary incontinence sexual questionnaire
Frequencies of surgical and post-operative complications	up to 2 years post-operatively	Complications will be classified and reported, based on severity.

Trial Locations

Locations (1)

Brigham And Women's Hospital; 🇺🇸 Boston, Massachusetts, United States