Back to resultsTransobturator Approach for Paravaginal Repair
Primary Purpose
Cystocele
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
transobturator approach for paravaginal repair
Sponsored by
About this trial
This is an interventional treatment trial for Cystocele
Eligibility Criteria
Inclusion Criteria:
- paravaginal defect cystocele
- midline and paravaginal defect cystocele
Exclusion Criteria:
- uterine descent
- previous cystocele surgery
Sites / Locations
- Urogynecology Unit
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
cystocele
Arm Description
Arm: Patients with paravaginal defect cystocele Intervention: transobturator approach for paravaginal repair
Outcomes
Primary Outcome Measures
success rate
Evaluation of the postoperative degree of anterior vaginal wall descent using pelvic organ prolapse quantitative system
Secondary Outcome Measures
lateral vaginal fornices elevation
test is negative means success
Operative time
Operative time
Intraoperative blood loss
Blood loss during the operative procedure
Complications rate
Intraoperative and postoperative complications
Full Information
NCT ID
NCT02735772
First Posted
March 31, 2016
Last Updated
October 4, 2019
Sponsor
Ain Shams Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02735772
Brief Title
Transobturator Approach for Paravaginal Repair
Official Title
Transobturator Approach for Paravaginal Repair a New Approach
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
December 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
No
5. Study Description
Brief Summary
A new technique for Applying sutures to the white line in paravaginal repair.
Detailed Description
A new trial for transobturator repair of the paravaginal defect.
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
Single Group Assignment
Model Description
All Patients included in the study will undergo repair of paravaginal defect using tge new technique described in this study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cystocele
Arm Type
Other
Arm Description
Arm: Patients with paravaginal defect cystocele
Intervention: transobturator approach for paravaginal repair
Intervention Type
Procedure
Intervention Name(s)
transobturator approach for paravaginal repair
Intervention Description
using TOT needle to apply suturs to white line
Primary Outcome Measure Information:
Title
success rate
Description
Evaluation of the postoperative degree of anterior vaginal wall descent using pelvic organ prolapse quantitative system
Time Frame
6 months
Secondary Outcome Measure Information:
Title
lateral vaginal fornices elevation
Description
test is negative means success
Time Frame
3 month
Title
Operative time
Description
Operative time
Time Frame
1 day
Title
Intraoperative blood loss
Description
Blood loss during the operative procedure
Time Frame
1 day
Title
Complications rate
Description
Intraoperative and postoperative complications
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Hazem SH Samoor, Professor
Organizational Affiliation
Ain Shams Universty
Official's Role
Study Chair
Facility Information:
Facility Name
Urogynecology Unit
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transobturator Approach for Paravaginal Repair
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