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
  • Procedure: Transobturator Paravaginal Repair
  • Procedure: traditional transvaginal Paravaginal Repair
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

  1. Operative data [1 day]

    Operative time

Secondary Outcome Measures

  1. Pelvic organ prolapse quantification system [3 month]

    Evaluation of the postoperative degree of anterior vaginal wall descent

  2. 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:

Study Results

No Results Posted as of Apr 9, 2018