Transvaginal Versus Transobturator Paravaginal Repair
Sponsor
Ain Shams Maternity Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03489902
Collaborator
(none)
40
2
13.9
Study Details
Study Description
Brief Summary
Clinical trial comparing the new technique for paravaginal repair versus the traditional technique
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
trial comparing the transobturator paravaginal repair versus the traditional technique
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transvaginal Versus Transobturator Paravaginal Repair Trial
Actual Study Start Date
:
Jan 1, 2017
Actual Primary Completion Date
:
Dec 31, 2017
Actual Study Completion Date
:
Mar 1, 2018
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Transobturator arm Transobturator Paravaginal Repair |
Procedure: Transobturator Paravaginal Repair
Transobturator application of sutures to the white line in cases needing paravaginal repair
|
Experimental: Transvaginal arm traditional transvaginal Paravaginal Repair |
Procedure: traditional transvaginal Paravaginal Repair
traditional transvaginal application of sutures to the white line
|
Outcome Measures
Primary Outcome Measures
- Operative data [1 day]
Operative time
Secondary Outcome Measures
- Pelvic organ prolapse quantification system [3 month]
Evaluation of the postoperative degree of anterior vaginal wall descent
- Operative Details [1 day]
blood loss
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
paravaginal defect cystocele
midline and paravaginal defect cystocele
Exclusion Criteria:
- uterine descent previous cystocele surgery
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ain Shams Maternity Hospital
Investigators
- Principal Investigator: Hamdy HA Saaid, MD, Ain Shams University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hamdy Ahmed Saaid,
Fellow of obstetrics & gynecology,
Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier:
NCT03489902
Other Study ID Numbers:
- TVTOPVR
First Posted:
Apr 6, 2018
Last Update Posted:
Apr 9, 2018
Last Verified:
Apr 1, 2018
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: