Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse

Not Applicable

• Conditions: Prolapse of Vaginal Vault After Hysterectomy
• Interventions: Procedure: uterosacral ligament suspension colpopexy bilateral

• Registration Number: NCT01364025
• Lead Sponsor: Kaiser Permanente

Brief Summary

Is routine uterosacral ligament suspension an appropriate clinical adjunct at the time of hysterectomy?

The answers to these questions will facilitate the treatment of many American women. With the results of this study, the investigators would anticipate a reduction in the number of surgeries for pelvic organ prolapse. In addition, if uterosacral ligament suspension was shown to be ineffective, it would not be used routinely in the setting of hysterectomy and women will be spared the additional procedure and possibility of side effects or complications.

The relative risks and benefits of adding a prophylactic uterosacral ligament suspension at the time of hysterectomy in women without symptomatic prolapse symptoms have never been studied prospectively.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Study Start: 2011-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25
• Primary Completion: 2021-02-21
• Study Completion: 2021-02-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 800

Inclusion Criteria

• Eligibility for primary procedure (hysterectomy either total or supracervical, performed either vaginally or abdominally, via laparoscopic or open approach)
• Eligibility for secondary procedure (uterosacral ligament suspension colpopexy)
• Prolapse in any compartment not extending beyond the hymen as measured by Pelvic Organ Prolapse Quantitative system
• No subjective complaints of Pelvic Organ Prolapse as determined by answer "no" to questions #3 of the short form of Pelvic Floor Distress Inventory: #3. Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?

Exclusion Criteria

• Contraindication for uterosacral ligament suspension colpopexy. (Surgeon's judgment that a contraindication to uterosacral ligament suspension colpopexy exists).
• Anticipated geographic relocation within the 12 months after surgery
• Inability to provide informed consent or to complete testing or data collection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
uterosacral ligament suspension	uterosacral ligament suspension colpopexy bilateral	uterosacral ligament suspension colpopexy sutures will be placed bilaterally at the time of hysterectomy

Primary Outcome Measures

Name	Time	Method
To compare the occurrence of objective findings of pelvic organ prolapse beyond hymen after uterosacral ligament suspension of the vaginal apex at the time of hysterectomy vs. hysterectomy alone using Pelvic Floor Quantitative Examination	one year and annual thereafter for 5 years

Trial Locations

Locations (1)

Kaiser Permanente San Diego; 🇺🇸 San Diego, California, United States