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Clinical Trials/NCT03922295
NCT03922295
Completed
N/A

Endoscopic Tympanoplasty: Single Versus Double Flap Technique

Mansoura University1 site in 1 country100 target enrollmentAugust 24, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tympanic Membrane Perforation
Sponsor
Mansoura University
Enrollment
100
Locations
1
Primary Endpoint
Healing or graft take rate
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Aim of this study is to compare results of double and single flap techniques for tympanoplasty in chronic suppurative otitis media patients. Inclusion criteria include total or subtotal tympanic membrane perforations with limited anterior remnant and should be dry for at least 3 months. Patients with persistent discharge, cholesteatoma, ossicular affection or those with recurrent perforations after previous myringoplasty were excluded. Also, patients with uncontrolled diabetes, chronic liver and kidney diseases and immuno-compromised patients are not included in this study. Patients are divided into two groups, endoscopic double flap group and endoscopic single flap group. Healing and hearing outcomes were evaluated 3 months postoperative. Also, post-operative pain scores and complications were assessed.

Registry
clinicaltrials.gov
Start Date
August 24, 2017
End Date
February 20, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Noha A.Elkholy

ORL-HNS Resident

Mansoura University

Eligibility Criteria

Inclusion Criteria

  • Patients with chronic suppurative otitis media with total or subtotal tympanic membrane perforation with limited anterior remnant.
  • dry perforation for at least 3 months.

Exclusion Criteria

  • Recurrent perforation after previous myringoplasty.
  • Ossicular disruption or fixation.
  • immune-compromised patients including uncontrolled diabetics, chronic liver and kidney diseases.

Outcomes

Primary Outcomes

Healing or graft take rate

Time Frame: 3 months after surgery

closure of tympanic membrane perforation

Study Sites (1)

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