Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse
This trial is active, not recruiting.
|Condition||prolapse of vaginal vault after hysterectomy|
|Treatment||uterosacral ligament suspension colpopexy bilateral|
|Collaborator||Massachusetts General Hospital|
|Start date||August 2011|
|End date||April 2019|
|Trial size||800 participants|
|Trial identifier||NCT01364025, PULS|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
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
time frame: one year and annual thereafter for 5 years
Female participants at least 21 years old.
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.
|Official title||Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse (PULS)|
|Principal investigator||Marianna Alperin, MD|
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