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0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse

Primary Purpose

Vaginal Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VNOTES/VH
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Prolapse

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women with vaginal prolapse
  • capable of having a surgery - assessed by an anesthesiologist
  • women who approve of having the surgery

Exclusion Criteria:

  • BMI over 40
  • women who have recurrent PID (pelvic inflammatory disease)
  • women with oncology records

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    VNOTES ARM

    Vaginal hysterectomy Arm

    Arm Description

    treatment of Vaginal prolapse with VNOTES surgery and apical suspension to the uterosacral ligaments.

    treatment of Vaginal prolapse with classic vaginal hysterectomy surgery and apical suspension to the uterosacral ligaments.

    Outcomes

    Primary Outcome Measures

    surgery time
    time of surgery

    Secondary Outcome Measures

    bleeding
    bleeding at surgery - volume of blood loss estimated by the surgeon performing the operation.
    hospital days
    how many days after surgery for hospitalization
    PISQ12 score - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
    Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire is a scoring index used to measure sexual function of women affected by pelvic organ prolapse. range 0-48. 0 marks good sexual function and 48 measures sexual disability affected from pelvic organ prolapse
    PFDI score - Pelvic Floor Disability Index
    The Pelvic Floor Disability Index is an index used to obtain an objective score regarding pelvic floor disability comprising of bowel, bladder, or pelvic symptoms over the last 3 months prior to answering the questionnaire. score ranges 0-300. 0 outcome is no pelvic floor disability and 300 marks a high level of pelvic floor disability.

    Full Information

    First Posted
    September 2, 2019
    Last Updated
    September 5, 2019
    Sponsor
    Rambam Health Care Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04078802
    Brief Title
    0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse
    Official Title
    Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared With Traditional Vaginal Utero-sacral Ligament Suspension for Vaginal Apex Prolapse
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2019 (Anticipated)
    Primary Completion Date
    October 2020 (Anticipated)
    Study Completion Date
    November 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

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

    5. Study Description

    Brief Summary
    VNOTES (Transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for Hysterectomy and Uterosacral ligament suspension to treat Vaginal prolapse. The investigators wish to run a randomized control trial comparing it to classic Vaginal hysterectomy for the same indication.
    Detailed Description
    The investigators will recruit 60 women with indication for surgery to treat uterine prolapse. 30 women will undergo VNOTES surgery and 30 women will undergo classic vaginal hysterectomy. The investigators will compare outcomes of the surgeries such as surgery time, bleeding and clinical outcomes after 3 and 6 months post operation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vaginal Prolapse

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    VNOTES ARM
    Arm Type
    Experimental
    Arm Description
    treatment of Vaginal prolapse with VNOTES surgery and apical suspension to the uterosacral ligaments.
    Arm Title
    Vaginal hysterectomy Arm
    Arm Type
    Experimental
    Arm Description
    treatment of Vaginal prolapse with classic vaginal hysterectomy surgery and apical suspension to the uterosacral ligaments.
    Intervention Type
    Procedure
    Intervention Name(s)
    VNOTES/VH
    Intervention Description
    same as above
    Primary Outcome Measure Information:
    Title
    surgery time
    Description
    time of surgery
    Time Frame
    from admission up to 6 hours post operation
    Secondary Outcome Measure Information:
    Title
    bleeding
    Description
    bleeding at surgery - volume of blood loss estimated by the surgeon performing the operation.
    Time Frame
    from admission up to 6 hours post operation
    Title
    hospital days
    Description
    how many days after surgery for hospitalization
    Time Frame
    from admission up to 96 hours post operation
    Title
    PISQ12 score - Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
    Description
    Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire is a scoring index used to measure sexual function of women affected by pelvic organ prolapse. range 0-48. 0 marks good sexual function and 48 measures sexual disability affected from pelvic organ prolapse
    Time Frame
    from admission up to 6 hours post operation
    Title
    PFDI score - Pelvic Floor Disability Index
    Description
    The Pelvic Floor Disability Index is an index used to obtain an objective score regarding pelvic floor disability comprising of bowel, bladder, or pelvic symptoms over the last 3 months prior to answering the questionnaire. score ranges 0-300. 0 outcome is no pelvic floor disability and 300 marks a high level of pelvic floor disability.
    Time Frame
    from admission up to 6 hours post operation

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    only women suffer from vaginal prolapse
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: women with vaginal prolapse capable of having a surgery - assessed by an anesthesiologist women who approve of having the surgery Exclusion Criteria: BMI over 40 women who have recurrent PID (pelvic inflammatory disease) women with oncology records
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Omer Mor, mD
    Phone
    972546486414
    Email
    omermor23@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Omer Mor, MD
    Organizational Affiliation
    Rambam Health Care Campus
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    0050-19-RMB CTIL - VNOTES Compared to VH for Vaginal Apex Prolapse

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