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Transvaginal Versus Transobturator Paravaginal Repair

Primary Purpose

Cystocele

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transobturator Paravaginal Repair
traditional transvaginal Paravaginal Repair
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystocele

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

paravaginal defect cystocele

midline and paravaginal defect cystocele

Exclusion Criteria:

  • uterine descent previous cystocele surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Transobturator arm

    Transvaginal arm

    Arm Description

    Transobturator Paravaginal Repair

    traditional transvaginal Paravaginal Repair

    Outcomes

    Primary Outcome Measures

    Operative data
    Operative time

    Secondary Outcome Measures

    Pelvic organ prolapse quantification system
    Evaluation of the postoperative degree of anterior vaginal wall descent
    Operative Details
    blood loss

    Full Information

    First Posted
    March 28, 2018
    Last Updated
    April 6, 2018
    Sponsor
    Ain Shams Maternity Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03489902
    Brief Title
    Transvaginal Versus Transobturator Paravaginal Repair
    Official Title
    Transvaginal Versus Transobturator Paravaginal Repair Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    December 31, 2017 (Actual)
    Study Completion Date
    March 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams Maternity Hospital

    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
    Clinical trial comparing the new technique for paravaginal repair versus the traditional technique
    Detailed Description
    trial comparing the transobturator paravaginal repair versus the traditional technique

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Transobturator arm
    Arm Type
    Experimental
    Arm Description
    Transobturator Paravaginal Repair
    Arm Title
    Transvaginal arm
    Arm Type
    Experimental
    Arm Description
    traditional transvaginal Paravaginal Repair
    Intervention Type
    Procedure
    Intervention Name(s)
    Transobturator Paravaginal Repair
    Intervention Description
    Transobturator application of sutures to the white line in cases needing paravaginal repair
    Intervention Type
    Procedure
    Intervention Name(s)
    traditional transvaginal Paravaginal Repair
    Intervention Description
    traditional transvaginal application of sutures to the white line
    Primary Outcome Measure Information:
    Title
    Operative data
    Description
    Operative time
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Pelvic organ prolapse quantification system
    Description
    Evaluation of the postoperative degree of anterior vaginal wall descent
    Time Frame
    3 month
    Title
    Operative Details
    Description
    blood loss
    Time Frame
    1 day

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: paravaginal defect cystocele midline and paravaginal defect cystocele Exclusion Criteria: uterine descent previous cystocele surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hamdy HA Saaid, MD
    Organizational Affiliation
    Ain Shams University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Transvaginal Versus Transobturator Paravaginal Repair

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