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

Pelvic Organ Prolapse Clinical Trial

— LULS-1  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03553511
• Other study ID #: LULS-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: May 2024

Study information

• Verified date: September 2021
• Source: Università degli Studi dell'Insubria
• Contact: Antonio Simone Laganà, M.D.
• Phone: 3296279579
• Email: antoniosimone.lagana[@]asst-settelaghi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2024
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Vaginal vault suspension to the uterosacral ligaments
Laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments
• McCall culdoplasty
Vaginal hysterectomy with McCall culdoplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Vaginal vault prolapse	12 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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