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Trial record 24 of 626 for:    transvaginal

Transvaginal Versus Transobturator Paravaginal Repair

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ClinicalTrials.gov Identifier: NCT03489902
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Hamdy Ahmed Saaid, Ain Shams Maternity Hospital

Brief Summary:
Clinical trial comparing the new technique for paravaginal repair versus the traditional technique

Condition or disease Intervention/treatment Phase
Cystocele Procedure: Transobturator Paravaginal Repair Procedure: traditional transvaginal Paravaginal Repair Not Applicable

Detailed Description:
trial comparing the transobturator paravaginal repair versus the traditional technique

Study Type : Interventional  (Clinical Trial)
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 : January 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : March 1, 2018

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




Primary Outcome Measures :
  1. Operative data [ Time Frame: 1 day ]
    Operative time


Secondary Outcome Measures :
  1. Pelvic organ prolapse quantification system [ Time Frame: 3 month ]
    Evaluation of the postoperative degree of anterior vaginal wall descent

  2. Operative Details [ Time Frame: 1 day ]
    blood loss



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

paravaginal defect cystocele

midline and paravaginal defect cystocele

Exclusion Criteria:

  • uterine descent previous cystocele surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489902


Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
Principal Investigator: Hamdy HA Saaid, MD Ain Shams University

Responsible Party: Hamdy Ahmed Saaid, Fellow of obstetrics & gynecology, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03489902     History of Changes
Other Study ID Numbers: TVTOPVR
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
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
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical