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
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
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
NCT ID
NCT03553511
First Posted
May 30, 2018
Last Updated
September 28, 2021
Sponsor
Università degli Studi dell'Insubria
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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