Endoscopic Tympanoplasty: Single Versus Double Flap Technique

Mansoura University

Status: Completed

Conditions: Tympanic Membrane Perforation

Treatments: Procedure: Endoscopic tympanoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03922295

1ORL

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

endoscopic double flap group

Active Comparator group

Treatment:

Procedure: Endoscopic tympanoplasty

endoscopic single flap group

Active Comparator group

Treatment:

Procedure: Endoscopic tympanoplasty