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

Primary Purpose

Pelvic Organ Prolapse

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vaginal vault suspension to the uterosacral ligaments
McCall culdoplasty
Sponsored by
Università degli Studi dell'Insubria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pelvic Organ Prolapse focused on measuring Laparoscopy, Hysterectomy, Uterosacral ligaments suspension, McCall culdoplasty, Post-hysterectomy vault prolapse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Uterosacral ligaments suspension

    McCall culdoplasty

    Arm Description

    Women affected by stage II-III pelvic organ prolapse undergoing total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments.

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

    Outcomes

    Primary Outcome Measures

    Recurrence
    Vaginal vault prolapse

    Secondary Outcome Measures

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    May 30, 2018
    Last Updated
    September 28, 2021
    Sponsor
    Università degli Studi dell'Insubria
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03553511
    Brief Title
    Laparoscopic Hysterectomy With Vaginal Vault Suspension to the Uterosacral Ligaments for Stage II-III Pelvic Organ Prolapse.
    Acronym
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    May 2023 (Anticipated)
    Study Completion Date
    May 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Università degli Studi dell'Insubria

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Organ Prolapse
    Keywords
    Laparoscopy, Hysterectomy, Uterosacral ligaments suspension, McCall culdoplasty, Post-hysterectomy vault prolapse

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective Randomized Clinical trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Uterosacral ligaments suspension
    Arm Type
    Experimental
    Arm Description
    Women affected by stage II-III pelvic organ prolapse undergoing total laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments.
    Arm Title
    McCall culdoplasty
    Arm Type
    Active Comparator
    Arm Description
    Women affected by stage II-III pelvic organ prolapse undergoing vaginal hysterectomy with McCall culdoplasty.
    Intervention Type
    Procedure
    Intervention Name(s)
    Vaginal vault suspension to the uterosacral ligaments
    Intervention Description
    Laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments
    Intervention Type
    Procedure
    Intervention Name(s)
    McCall culdoplasty
    Intervention Description
    Vaginal hysterectomy with McCall culdoplasty
    Primary Outcome Measure Information:
    Title
    Recurrence
    Description
    Vaginal vault prolapse
    Time Frame
    12 months after surgery
    Secondary Outcome Measure Information:
    Title
    Urinary impact questionnaire score (total score minimum: 0, maximum: 100)
    Description
    A specific questionnaire developed to investigate the impact of urinary symptoms and signs on the quality of life.
    Time Frame
    12 months after surgery
    Title
    Pelvic Organ Prolapse Impact Questionnaire (total score minimum: 0, maximum: 100)
    Description
    A specific questionnaire developed to investigate the impact of prolapse-related symptoms and signs on the quality of life.
    Time Frame
    12 months after surgery
    Title
    Colorectal-Anal Impact questionnaire (total score minimum: 0, maximum: 100)
    Description
    A specific questionnaire developed to investigate the impact of prolapse-related colorectal and anal symptoms and signs on the quality of life.
    Time Frame
    12 months after surgery
    Title
    Prolapse/urinary incontinence sexual questionnaire score (total score minimum: 0, maximum: 48)
    Description
    A specific questionnaire developed to investigate the impact of prolapse/urinary incontinence on sexual functions.
    Time Frame
    12 months after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Antonio Simone Laganà, M.D.
    Phone
    3296279579
    Ext
    +39
    Email
    antoniosimone.lagana@asst-settelaghi.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antonio Simone Laganà, M.D.
    Organizational Affiliation
    Università degli Studi dell'Insubria
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jvan Casarin, M.D.
    Organizational Affiliation
    Università degli Studi dell'Insubria
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Antonella Cromi, M.D., Ph.D.
    Organizational Affiliation
    Università degli Studi dell'Insubria
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Fabio Ghezzi, M.D.
    Organizational Affiliation
    Università degli Studi dell'Insubria
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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