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

Not Applicable

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: McCall culdoplasty; Procedure: Vaginal vault suspension to the uterosacral ligaments

• Registration Number: NCT03553511
• Lead Sponsor: Università degli Studi dell'Insubria

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-30
• Study Start: 2022-05
• Primary Completion: 2023-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
McCall culdoplasty	McCall culdoplasty	Women affected by stage II-III pelvic organ prolapse undergoing vaginal hysterectomy with McCall culdoplasty.
Uterosacral ligaments suspension	Vaginal vault suspension to the uterosacral ligaments	Women affected by stage II-III pelvic organ prolapse undergoing total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments.

Primary Outcome Measures

Name	Time	Method
Recurrence	12 months after surgery	Vaginal vault prolapse

Secondary Outcome Measures

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