Endoscopic Tympanoplasty: Single Versus Double Flap Technique

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-24

Study Completion Date

2019-02-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Tympanic Membrane Perforation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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endoscopic double flap group

Group Type ACTIVE_COMPARATOR

Endoscopic tympanoplasty

Intervention Type PROCEDURE

In the double flap group, graft is placed via elevation of both posterior and anterior flaps.

In the single flap group, graft is placed via elevation of posterior flap only

endoscopic single flap group

Group Type ACTIVE_COMPARATOR

Endoscopic tympanoplasty

Intervention Type PROCEDURE

In the double flap group, graft is placed via elevation of both posterior and anterior flaps.

In the single flap group, graft is placed via elevation of posterior flap only

Interventions

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