Comparison of Laparoscopic to Vaginal Surgical Repair for Uterine Prolapse

NCT ID: NCT01594372

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-05-31

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.

Conditions

Uterine Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic Repair

Laparoscopic supracervical hysterectomy with sacropexy

Group Type: ACTIVE_COMPARATOR

Laparoscopic supracervical hysterectomy with sacropexy

Intervention Type: PROCEDURE

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 Repair

Vaginal hysterectomy with uterosacral colposuspension

Group Type: ACTIVE_COMPARATOR

Vaginal hysterectomy with uterosacral colposuspension

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Vatche Arakel Minassian

Director of Urogynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vatche A Minassian, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham And Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

VM-2012-01

Identifier Type: -

Identifier Source: org_study_id