Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

Randomized Trial Comparing Vaginal Hysterectomy to Laparoscopic Supracervical Hysterectomy With Vault Suspension for Symptomatic Uterine Prolapse

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 Overview

• Status: Terminated
• Conditions: Uterine Prolapse
• Intervention / Treatment: Procedure: Laparoscopic supracervical hysterectomy with sacropexy; Procedure: Vaginal hysterectomy with uterosacral colposuspension

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopic Repair; Laparoscopic supracervical hysterectomy with sacropexy	Procedure: Laparoscopic supracervical hysterectomy with sacropexy; 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
Active Comparator: Vaginal Repair; Vaginal hysterectomy with uterosacral colposuspension	Procedure: Vaginal hysterectomy with uterosacral colposuspension; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Absence of re-treatment for prolapse at 2 years		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).	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Vatche A Minassian, MD, MPH, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 4, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 9, 2012

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Laparoscopy; Uterine Prolapse; Hysterectomy, vaginal
• Additional Relevant MeSH Terms: Uterine Diseases; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Prolapse; Uterine Prolapse
• Other Study ID Numbers: VM-2012-01