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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2021-02-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Prolapse of Vaginal Vault After Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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uterosacral ligament suspension

uterosacral ligament suspension colpopexy sutures will be placed bilaterally at the time of hysterectomy

Group Type EXPERIMENTAL

uterosacral ligament suspension colpopexy bilateral

Intervention Type PROCEDURE

Uterosacral ligament suspension colpopexy bilateral

hysterectomy alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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uterosacral ligament suspension colpopexy bilateral

Uterosacral ligament suspension colpopexy bilateral

Intervention Type PROCEDURE

Other Intervention Names

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uterosacral ligament suspension at the time of hysterectomy

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No