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

Study Overview
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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.

Official Title
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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
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Vaginal vault suspension to the uterosacral ligaments
* Procedure: McCall culdoplasty


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Randomized Clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uterosacral ligaments suspension<br>Women affected by stage II-III pelvic organ prolapse undergoing total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments. | Procedure: Vaginal vault suspension to the uterosacral ligaments<br>* Laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments<br>|
| Active Comparator: McCall culdoplasty<br>Women affected by stage II-III pelvic organ prolapse undergoing vaginal hysterectomy with McCall culdoplasty. | Procedure: McCall culdoplasty<br>* Vaginal hysterectomy with McCall culdoplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Vaginal vault prolapse | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary impact questionnaire score (total score minimum: 0, maximum: 100) | A specific questionnaire developed to investigate the impact of urinary symptoms and signs on the quality of life. | 12 months after surgery | 
| Pelvic Organ Prolapse Impact Questionnaire (total score minimum: 0, maximum: 100) | A specific questionnaire developed to investigate the impact of prolapse-related symptoms and signs on the quality of life. | 12 months after surgery | 
| Colorectal-Anal Impact questionnaire (total score minimum: 0, maximum: 100) | A specific questionnaire developed to investigate the impact of prolapse-related colorectal and anal symptoms and signs on the quality of life. | 12 months after surgery | 
| Prolapse/urinary incontinence sexual questionnaire score (total score minimum: 0, maximum: 48) | A specific questionnaire developed to investigate the impact of prolapse/urinary incontinence on sexual functions. | 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterosacral ligaments suspension, Laparoscopy, Hysterectomy, McCall culdoplasty, Post-hysterectomy vault prolapse