Clinical Trials Directory

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UnknownNCT03553511

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

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.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Università degli Studi dell'Insubria · Academic / Other
Sex
Female
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREVaginal vault suspension to the uterosacral ligamentsLaparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments
PROCEDUREMcCall culdoplastyVaginal hysterectomy with McCall culdoplasty

Timeline

Start date
2022-05-01
Primary completion
2023-05-01
Completion
2024-05-01
First posted
2018-06-12
Last updated
2021-09-30

Source: ClinicalTrials.gov record NCT03553511. Inclusion in this directory is not an endorsement.