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Laparoscopic Hysterectomy With Vaginal Vault Suspension to the Uterosacral Ligaments for Stage II-III Pelvic Organ Prolapse.

NCT03553511 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-09-30

No results posted yet for this study

Summary

The International Continence Society defines post-hysterectomy vault prolapse (PHVP) as descent of the vaginal cuff scar below a point that is 2 cm less than the total vaginal length above the plane of the hymen. The incidence of PHVP has been reported to affect up to 43% of hysterectomies. The risk of prolapse following hysterectomy is 5.5 times more common in women whose initial hysterectomy was for pelvic organ prolapse as opposed to other reasons.

Techniques available to manage PHVP aim to ultimately suspend the vaginal vault. Approaches include vaginal, e.g. uterosacral ligament suspension, sacrospinous ligament fixation, open procedures and more recently laparoscopic, e.g. sacrocolpopexy and uterosacral plication.

Data published so far do not allow to draw a firm conclusion about the best treatment to prevent PHVP for women undergoing hysterectomy for stage II-III pelvic organ prolapse. Considering this scenario, in the current study the investigators aim to evaluate short and long-term outcomes after total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments versus vaginal hysterectomy with McCall culdoplasty for the treatment of stage II-III pelvic organ prolapse.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

Vaginal vault suspension to the uterosacral ligaments

Laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments

PROCEDURE

McCall culdoplasty

Vaginal hysterectomy with McCall culdoplasty

Sponsors & Collaborators

  • Università degli Studi dell'Insubria

    lead OTHER

Principal Investigators

  • Antonio Simone Laganà, M.D. · Università degli Studi dell'Insubria

  • Jvan Casarin, M.D. · Università degli Studi dell'Insubria

  • Antonella Cromi, M.D., Ph.D. · Università degli Studi dell'Insubria

  • Fabio Ghezzi, M.D. · Università degli Studi dell'Insubria

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2023-05-31
Completion
2024-05-31

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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 NCT03553511 on ClinicalTrials.gov