Back to resultsEndoscopic Tympanoplasty: Single Versus Double Flap Technique
Primary Purpose
Tympanic Membrane Perforation
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endoscopic tympanoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Tympanic Membrane Perforation
Eligibility 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.
Sites / Locations
- ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
endoscopic double flap group
endoscopic single flap group
Arm Description
Outcomes
Primary Outcome Measures
Healing or graft take rate
closure of tympanic membrane perforation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03922295
Brief Title
Endoscopic Tympanoplasty: Single Versus Double Flap Technique
Official Title
Endoscopic Tympanoplasty: Single Versus Double Flap Technique
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 24, 2017 (Actual)
Primary Completion Date
February 20, 2019 (Actual)
Study Completion Date
February 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tympanic Membrane Perforation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
endoscopic double flap group
Arm Type
Active Comparator
Arm Title
endoscopic single flap group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Endoscopic tympanoplasty
Intervention Description
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 Outcome Measure Information:
Title
Healing or graft take rate
Description
closure of tympanic membrane perforation
Time Frame
3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noha A Elkholy
Organizational Affiliation
ORL-HNS department, Faculty of Medicine, Mansoura University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammed A Salem
Organizational Affiliation
ORL-HNS department, Faculty of Medicine, Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abdelwahab M Rakha
Organizational Affiliation
ORL-HNS department, Faculty of Medicine, Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
City
Mansoura
State/Province
ElDakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
32691232
Citation
El-Kholy NA, Salem MA, Rakha AM. Endoscopic single versus double flap tympanoplasty: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2021 May;278(5):1395-1401. doi: 10.1007/s00405-020-06212-3. Epub 2020 Jul 20.
Results Reference
derived
Learn more about this trial
Endoscopic Tympanoplasty: Single Versus Double Flap Technique
We'll reach out to this number within 24 hrs