Endoscopic Tympanoplasty: Single Versus Double Flap Technique

Tympanic Membrane Perforation Clinical Trial

Official title:

Endoscopic Tympanoplasty: Single Versus Double Flap Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922295
• Other study ID #: 1ORL
• Status: Completed
• Phase: N/A
• Start date: August 24, 2017
• Est. completion date: February 20, 2019

Study information

• Verified date: September 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 20, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tympanic Membrane Perforation

Intervention

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

Locations

Country	Name	City	State
Egypt	ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University	Mansoura	ElDakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing or graft take rate	closure of tympanic membrane perforation	3 months after surgery