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NCT02735772 Clinical Trial

Transobturator Approach for Paravaginal Repair

Cystocele Clinical Trial

Official title:
Transobturator Approach for Paravaginal Repair a New Approach

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02735772
Other study ID # PVRNA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 25, 2017
Est. completion date December 1, 2018

Study information
Verified date October 2019
Source Ain Shams Maternity Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A new technique for Applying sutures to the white line in paravaginal repair.

Description:

A new trial for transobturator repair of the paravaginal defect.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- paravaginal defect cystocele

- midline and paravaginal defect cystocele

Exclusion Criteria:

- uterine descent

- previous cystocele surgery

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• transobturator approach for paravaginal repair
using TOT needle to apply suturs to white line

Locations
Country Name City State
Egypt Urogynecology Unit Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary success rate Evaluation of the postoperative degree of anterior vaginal wall descent using pelvic organ prolapse quantitative system 6 months
Secondary lateral vaginal fornices elevation test is negative means success 3 month
Secondary Operative time Operative time 1 day
Secondary Intraoperative blood loss Blood loss during the operative procedure 1 day
Secondary Complications rate Intraoperative and postoperative complications 1 week
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