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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective Randomized Clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Uterosacral ligaments suspension

Women affected by stage II-III pelvic organ prolapse undergoing total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments.

Group Type EXPERIMENTAL

Vaginal vault suspension to the uterosacral ligaments

Intervention Type PROCEDURE

Laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments

McCall culdoplasty

Women affected by stage II-III pelvic organ prolapse undergoing vaginal hysterectomy with McCall culdoplasty.

Group Type ACTIVE_COMPARATOR

McCall culdoplasty

Intervention Type PROCEDURE

Vaginal hysterectomy with McCall culdoplasty

Interventions

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Vaginal vault suspension to the uterosacral ligaments

Laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments

Intervention Type PROCEDURE

McCall culdoplasty

Vaginal hysterectomy with McCall culdoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Stage II-III pelvic organ prolapse
* Bilateral preservation of the ovaries
* Sexually active women

Exclusion Criteria

* Smoking
* Body Mass Index \> 30
* Strenuous activity (frequent heavy lifting)
* Other gynecological and non-gynecological (chronic endocrine, metabolic, autoimmune, neoplastic diseases) comorbidities
* Pharmacological and/or nonpharmacological treatment (including pelvic floor exercises) in the six months preceding the surgery or during the study period

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No