Endoscopic Tympanoplasty: Single Versus Double Flap Technique

Not Applicable

Completed

• Conditions: Tympanic Membrane Perforation
• Interventions: Procedure: Endoscopic tympanoplasty

• Registration Number: NCT03922295
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-08-24
• Primary Completion: 2019-02-20
• Study Completion: 2019-02-20
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-19
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopic double flap group	Endoscopic tympanoplasty	-
endoscopic single flap group	Endoscopic tympanoplasty	-

Primary Outcome Measures

Name	Time	Method
Healing or graft take rate	3 months after surgery	closure of tympanic membrane perforation

Trial Locations

Locations (1)

ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University; 🇪🇬 Mansoura, ElDakahlia, Egypt