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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoscopic double flap group | Active Comparator |
| |
| endoscopic single flap group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Healing or graft take rate | closure of tympanic membrane perforation | 3 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noha A Elkholy | ORL-HNS department, Faculty of Medicine, Mansoura University | Principal Investigator |
| Mohammed A Salem | ORL-HNS department, Faculty of Medicine, Mansoura University | Study Director |
| Abdelwahab M Rakha | ORL-HNS department, Faculty of Medicine, Mansoura University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University | Al Mansurah | ElDakahlia | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32691232 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2017 | Apr 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018058 | Tympanic Membrane Perforation |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
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