Endoscopic Tympanoplasty: Single Versus Double Flap Technique

September 6, 2019 updated by: Noha A.Elkholy, Mansoura University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • ElDakahlia
      • Mansoura, ElDakahlia, Egypt, 35516
        • ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: endoscopic double flap group
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
Active Comparator: endoscopic single flap group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing or graft take rate
Time Frame: 3 months after surgery
closure of tympanic membrane perforation
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Noha A Elkholy, ORL-HNS department, Faculty of Medicine, Mansoura University
  • Study Director: Mohammed A Salem, ORL-HNS department, Faculty of Medicine, Mansoura University
  • Study Chair: Abdelwahab M Rakha, ORL-HNS department, Faculty of Medicine, Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2017

Primary Completion (Actual)

February 20, 2019

Study Completion (Actual)

February 20, 2019

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (Actual)

April 19, 2019

Study Record Updates

Last Update Posted (Actual)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 6, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1ORL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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