Clinical Trials Directory

Trials / Completed

CompletedNCT03922295

Endoscopic Tympanoplasty: Single Versus Double Flap Technique

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Mansoura University · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREEndoscopic tympanoplastyIn 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

Timeline

Start date
2017-08-24
Primary completion
2019-02-20
Completion
2019-02-20
First posted
2019-04-19
Last updated
2019-09-10

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03922295. Inclusion in this directory is not an endorsement.