NCT01594372

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2012-05-09
• Last updated: 2022-03-04

Locations

1 site across 1 country: United States