LULS-1: Laparoscopic Hysterectomy With Vaginal Vault Suspension to the Uterosacral Ligaments for Stage II-III Pelvic Organ Prolapse.

Sponsor

Università degli Studi dell'Insubria (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03553511

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Vaginal vault suspension to the uterosacral ligaments Procedure: McCall culdoplasty	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective Randomized Clinical trialProspective Randomized Clinical trial

Masking:

None (Open Label)

Primary Purpose:

Prevention

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.

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Uterosacral ligaments suspension 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 Laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments
Active Comparator: McCall culdoplasty Women affected by stage II-III pelvic organ prolapse undergoing vaginal hysterectomy with McCall culdoplasty.	Procedure: McCall culdoplasty Vaginal hysterectomy with McCall culdoplasty

Arm

Intervention/Treatment

Experimental: Uterosacral ligaments suspension

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

Laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments

Active Comparator: McCall culdoplasty

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

Procedure: McCall culdoplasty

Vaginal hysterectomy with McCall culdoplasty

Outcome Measures

Primary Outcome Measures

Recurrence [12 months after surgery]
Vaginal vault prolapse

Secondary Outcome Measures

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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Università degli Studi dell'Insubria

Investigators

Principal Investigator: Antonio Simone Laganà, M.D., Università degli Studi dell'Insubria
Principal Investigator: Jvan Casarin, M.D., Università degli Studi dell'Insubria
Study Chair: Antonella Cromi, M.D., Ph.D., Università degli Studi dell'Insubria
Study Director: Fabio Ghezzi, M.D., Università degli Studi dell'Insubria