Clinical trial NCT06982157: A Comparison Between Vaginal Sacrospinous Ligament Fixation and Laparoscopic Uterosacral Ligament Suspension as a Uterine Preserving Surgery for Pelvic Organ Prolapse
Official title: A Comparison Between Vaginal Sacrospinous Ligament Fixation and Laparoscopic Uterosacral Ligament Suspension as a Uterine Preserving Surgery for Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse (POP)
Pelvic Organ Prolapse Vaginal Surgery
Hysterectomy
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2025-05-21
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who underwent vaginal sacrospinous suspension and laparoscopic uterosacral Sacrospinous ligament fixation

Brief 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.

Detailed description: Vaginal hysterectomy, with or without repair, is the most common procedure performed for apical prolapse. The underlying etiology of apical prolapse is a weakness in the supports of the uterus and upper vagina. There is a growing body of evidence to suggest that uterine preserving procedures for treatment of prolapse are effective and safe. Vaginal sacrospinous hysteropexy is a relatively simple procedure which can be carried out by the generalist gynecologist who performs vaginal repairs.

Sacrospinous hysteropexy is a safe and effective procedure for pelvic organ prolapse and has comparable outcomes to vaginal hysterectomy with repair (3).

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 (4) The surgical management of multi-compartment prolapse is challenging and often requires a combination of techniques.

Eligibility criteria: Inclusion Criteria:

* From the general Urogynecological cohort who underwent vaginal sacrospinous suspension and laparoscopic uterosacral Sacrospinous ligament fixation at Hillel Yaffe Hospital.

Exclusion Criteria:

* None

Primary outcomes:
measure: Risks of anatomic and symptomatic POP after vaginal sacrospinous ligament fixation and laparoscopic uterosacral ligament suspension
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Jonia Alsheik, Dr
role: PRINCIPAL_INVESTIGATOR
References: