Transobturator Approach for Paravaginal Repair

• Sponsor: Ain Shams Maternity Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02735772
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 19.2
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cystocele	Procedure: transobturator approach for paravaginal repair	N/A

Detailed Description

A new trial for transobturator repair of the paravaginal defect.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All Patients included in the study will undergo repair of paravaginal defect using tge new technique described in this studyAll Patients included in the study will undergo repair of paravaginal defect using tge new technique described in this study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transobturator Approach for Paravaginal Repair a New Approach
• Actual Study Start Date: Apr 25, 2017
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: cystocele Arm: Patients with paravaginal defect cystocele Intervention: transobturator approach for paravaginal repair	Procedure: transobturator approach for paravaginal repair; using TOT needle to apply suturs to white line

Outcome Measures

Primary Outcome Measures

1. success rate [6 months]

   Evaluation of the postoperative degree of anterior vaginal wall descent using pelvic organ prolapse quantitative system

Secondary Outcome Measures

1. lateral vaginal fornices elevation [3 month]

   test is negative means success

2. Operative time [1 day]

   Operative time

3. Intraoperative blood loss [1 day]

   Blood loss during the operative procedure

4. Complications rate [1 week]

   Intraoperative and postoperative complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• paravaginal defect cystocele

• midline and paravaginal defect cystocele

Exclusion Criteria:

• uterine descent

• previous cystocele surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urogynecology Unit	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams Maternity Hospital

Investigators

• Study Chair: Hazem SH Samoor, Professor, Ain Shams Universty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hamdy Ahmed Saaid, Dr.Hamdy Ahmed, Ain Shams Maternity Hospital
• ClinicalTrials.gov Identifier: NCT02735772
• Other Study ID Numbers: PVRNA
• First Posted: Apr 13, 2016
• Last Update Posted: Oct 8, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cystocele

Study Results

No Results Posted as of Oct 8, 2019