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

NCT03553511 | Unknown DMC

• 1 other identifier: LULS-1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pelvic Organ Prolapse

Keywords

Laparoscopy; Hysterectomy; Uterosacral ligaments suspension; McCall culdoplasty; Post-hysterectomy vault prolapse

Outcome Measures

Primary Outcomes (1)

• Recurrence

  Vaginal vault prolapse

  12 months after surgery

Secondary Outcomes (4)

• Urinary impact questionnaire score (total score minimum: 0, maximum: 100)

  12 months after surgery

• Pelvic Organ Prolapse Impact Questionnaire (total score minimum: 0, maximum: 100)

  12 months after surgery

• Colorectal-Anal Impact questionnaire (total score minimum: 0, maximum: 100)

  12 months after surgery

• Prolapse/urinary incontinence sexual questionnaire score (total score minimum: 0, maximum: 48)

  12 months after surgery

Study Arms (2)

Uterosacral ligaments suspension

EXPERIMENTAL

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

McCall culdoplasty

ACTIVE COMPARATOR

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

Procedure: McCall culdoplasty

Interventions

Vaginal vault suspension to the uterosacral ligaments PROCEDURE

Laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments

Uterosacral ligaments suspension

McCall culdoplasty PROCEDURE

Vaginal hysterectomy with McCall culdoplasty

McCall culdoplasty

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Simone Laganà, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Jvan Casarin, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Antonella Cromi, M.D., Ph.D.

  Università degli Studi dell'Insubria

  STUDY CHAIR

• Fabio Ghezzi, M.D.

  Università degli Studi dell'Insubria

  STUDY DIRECTOR

Central Study Contacts

Antonio Simone Laganà, M.D.

CONTACT

3296279579; antoniosimone.lagana@asst-settelaghi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Prospective Randomized Clinical trial

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 12, 2018
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: September 30, 2021

Record last verified: 2021-09