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A Comparison Between Vaginal Sacrospinous Ligament Fixation and Laparoscopic Uterosacral Ligament Suspension as a Uterine Preserving Surgery for Pelvic Organ Prolapse

NCT06982157 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 111

Last updated 2025-11-18

No results posted yet for this study

Summary

The investigators present a literature review evaluating the current place of sacrospinous hysteropexy in the surgical management of pelvic organ prolapse. Additionally, to assess the efficacy of the procedure, the investigators performed a meta-analysis comparing sacrospinous hysteropexy with vaginal hysterectomy and repair in terms of anatomical outcomes, complications, and repeat surgery rates.

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.

Conditions

  • Pelvic Organ Prolapse (POP)
  • Pelvic Organ Prolapse Vaginal Surgery
  • Hysterectomy

Sponsors & Collaborators

  • Hillel Yaffe Medical Center

    lead OTHER_GOV

Principal Investigators

  • Jonia Alsheik, Dr · Hillel Yaffe Medical Center

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2022-07-07
Completion
2022-07-07

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06982157 on ClinicalTrials.gov