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OpenTrials
Completed

NCT Number: NCT03922295

Endoscopic Tympanoplasty: Single Versus Double Flap Technique

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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Key information

Conditions

Tympanic Membrane Perforation Ear Diseases Otorhinolaryngologic Diseases Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University

Al Mansurah, ElDakahlia, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic tympanoplasty

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

Primary outcomes

  1. Healing or graft take rate

    Time frame: 3 months after surgery

    closure of tympanic membrane perforation

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2019
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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