A Comparison Between Vaginal Sacrospinous Ligament Fixation and Laparoscopic Uterosacral Ligament Suspension as a Uterine Preserving Surgery for Pelvic Organ Prolapse
NCT ID: NCT06982157
Last Updated: 2025-11-18
Study Results
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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COMPLETED
111 participants
OBSERVATIONAL
2020-07-22
2022-07-07
Brief Summary
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Vaginal sacrospinous ligament fixation is associated with less anatomic recurrent prolapse and prolapse related symptoms compared with laparoscopic uterosacral ligament suspension in women desiring uterine preservation Hypothesis: Vaginal SSF and lap USLS may have comparable anatomic outcomes in repair of mild to mod uterine prolapse but LUSLS may be associated with longer OT while SSF with more post-op pelvic pain and a higher rate of future prolapse at the ant. Compartment.
Objective: In this study we aim to evaluate the risk of anatomic and symptomatic POP after vaginal sacrospinous ligament fixation and laparoscopic uterosacral ligament suspension among patients who underwent pelvic organ prolapse repair at a single university-affiliated maternity hospital, by comparing the clinical (symptoms - questionnaires) and anatomical (POP Q) outcomes between the two techniques 6, 12, 18, and 24 months following surgery, and therefore establishing personalized approach relying on pre-op parameters.
Specific Aims
* Specific aim 1: Evaluate the efficacy and safety of vaginal sacrospinous ligament fixation and laparoscopic uterosacral ligament suspension among patients who underwent pelvic organ prolapse repair at HY medical center.
* Specific aim 2: Compare the clinical (symptoms - questionnaires) and anatomical (POP Q) outcomes between the two techniques 6, 12, 18, and 24 months following surgery.
* Specific aim 3: Determine the patient characteristics that might delineate which surgery is appropriate for the given group.
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Detailed Description
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Sacrospinous hysteropexy is a safe and effective procedure for pelvic organ prolapse and has comparable outcomes to vaginal hysterectomy with repair.
Hysterectomy with laparoscopic uterosacral colpopexy has been shown to produce better objective success rates than laparoscopic uterosacral hysteropexy; however, repeat operation rates are not significantly different.
The surgical management of multi-compartment prolapse is challenging and often requires a combination of techniques.
Conditions
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Study Design
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CASE_CROSSOVER
RETROSPECTIVE
Study Groups
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Vaginal sacrospinous ligament fixation
Vaginal sacrospinous ligament fixation
No interventions assigned to this group
laparoscopic uterosacral ligament suspension
laparoscopic uterosacral ligament suspension
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
99 Years
FEMALE
Yes
Sponsors
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Hillel Yaffe Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Jonia Alsheik, Dr
Role: PRINCIPAL_INVESTIGATOR
Hillel Yaffe Medical Center
Locations
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Hille Yaffe Medical Center
Hadera, , Israel
Countries
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Other Identifiers
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0111-20-HYMC
Identifier Type: -
Identifier Source: org_study_id
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