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Endoscopic Tympanoplasty: Single Versus Double Flap Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03922295
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Noha A.Elkholy, Mansoura University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Tympanic Membrane Perforation Procedure: Endoscopic tympanoplasty Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Endoscopic Tympanoplasty: Single Versus Double Flap Technique
Actual Study Start Date : August 24, 2017
Actual Primary Completion Date : February 20, 2019
Actual Study Completion Date : February 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Healing or graft take rate [ Time Frame: 3 months after surgery ]
    closure of tympanic membrane perforation


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922295


Locations
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Egypt
ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
Mansoura, ElDakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Noha A.Elkholy, Mansoura University:
Study Protocol and Statistical Analysis Plan  [PDF] August 20, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Noha A.Elkholy, ORL-HNS Resident, Mansoura University
ClinicalTrials.gov Identifier: NCT03922295    
Other Study ID Numbers: 1ORL
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tympanic Membrane Perforation
Ear Diseases
Otorhinolaryngologic Diseases
Wounds and Injuries