Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553511
Recruitment Status : Not yet recruiting
First Posted : June 12, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Antonio Simone Laganà, Università degli Studi dell'Insubria

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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective 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.
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Recurrence [ Time Frame: 12 months after surgery ]
    Vaginal vault prolapse


Secondary Outcome Measures :
  1. Urinary impact questionnaire score (total score minimum: 0, maximum: 100) [ Time Frame: 12 months after surgery ]
    A specific questionnaire developed to investigate the impact of urinary symptoms and signs on the quality of life.

  2. Pelvic Organ Prolapse Impact Questionnaire (total score minimum: 0, maximum: 100) [ Time Frame: 12 months after surgery ]
    A specific questionnaire developed to investigate the impact of prolapse-related symptoms and signs on the quality of life.

  3. Colorectal-Anal Impact questionnaire (total score minimum: 0, maximum: 100) [ Time Frame: 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.

  4. Prolapse/urinary incontinence sexual questionnaire score (total score minimum: 0, maximum: 48) [ Time Frame: 12 months after surgery ]
    A specific questionnaire developed to investigate the impact of prolapse/urinary incontinence on sexual functions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553511


Contacts
Layout table for location contacts
Contact: Antonio Simone Laganà, M.D. 3296279579 ext +39 antoniosimone.lagana@asst-settelaghi.it

Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Antonio Simone Laganà, Medical Doctor, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03553511    
Other Study ID Numbers: LULS-1
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Simone Laganà, Università degli Studi dell'Insubria:
Laparoscopy
Hysterectomy
Uterosacral ligaments suspension
McCall culdoplasty
Post-hysterectomy vault prolapse
Additional relevant MeSH terms:
Layout table for MeSH terms
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical