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Endoscopic Tympanoplasty: Single Versus Double Flap Technique

NCT03922295 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-09-10

No results posted yet for this study

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.

Conditions

  • Tympanic Membrane Perforation

Interventions

PROCEDURE

Endoscopic tympanoplasty

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Noha A Elkholy · ORL-HNS department, Faculty of Medicine, Mansoura University

  • Mohammed A Salem · ORL-HNS department, Faculty of Medicine, Mansoura University

  • Abdelwahab M Rakha · ORL-HNS department, Faculty of Medicine, Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-24
Primary Completion
2019-02-20
Completion
2019-02-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03922295 on ClinicalTrials.gov