Endoscopic Tympanoplasty: Single Versus Double Flap Technique
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2019
CompletedFirst Submitted
Initial submission to the registry
April 16, 2019
CompletedFirst Posted
Study publicly available on registry
April 19, 2019
CompletedSeptember 10, 2019
September 1, 2019
1.5 years
April 16, 2019
September 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Healing or graft take rate
closure of tympanic membrane perforation
3 months after surgery
Study Arms (2)
endoscopic double flap group
ACTIVE COMPARATORendoscopic single flap group
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- Patients with chronic suppurative otitis media with total or subtotal tympanic membrane perforation with limited anterior remnant.
- dry perforation for at least 3 months.
You may not qualify if:
- Recurrent perforation after previous myringoplasty.
- Ossicular disruption or fixation.
- immune-compromised patients including uncontrolled diabetics, chronic liver and kidney diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
Al Mansurah, ElDakahlia, 35516, Egypt
Related Publications (1)
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.
PMID: 32691232DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ORL-HNS Resident
Study Record Dates
First Submitted
April 16, 2019
First Posted
April 19, 2019
Study Start
August 24, 2017
Primary Completion
February 20, 2019
Study Completion
February 20, 2019
Last Updated
September 10, 2019
Record last verified: 2019-09