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出境医 / 临床实验 / Endoscopic Tympanoplasty: Single Versus Double Flap Technique
Endoscopic Tympanoplasty: Single Versus Double Flap Technique
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tympanic Membrane Perforation | Procedure: Endoscopic tympanoplasty | Not Applicable |
Study Design
| 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 |
Arms and Interventions
| 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
Primary Outcome Measures :
- Healing or graft take rate [ Time Frame: 3 months after surgery ]closure of tympanic membrane perforation
Eligibility Criteria
| 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
Locations
| Egypt | |
| ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University | |
| Mansoura, ElDakahlia, Egypt, 35516 | |
Sponsors and Collaborators
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 |
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 16, 2019 | |||||||||
| First Posted Date ICMJE | April 19, 2019 | |||||||||
| Last Update Posted Date | September 10, 2019 | |||||||||
| Actual Study Start Date ICMJE | August 24, 2017 | |||||||||
| Actual Primary Completion Date | February 20, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Healing or graft take rate [ Time Frame: 3 months after surgery ] closure of tympanic membrane perforation
|
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Endoscopic Tympanoplasty: Single Versus Double Flap Technique | |||||||||
| Official Title ICMJE | Endoscopic Tympanoplasty: Single Versus Double Flap Technique | |||||||||
| 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. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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| Condition ICMJE | Tympanic Membrane Perforation | |||||||||
| Intervention ICMJE | 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 |
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| Study Arms ICMJE |
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| Publications * | 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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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
100 | |||||||||
| Original Actual Enrollment ICMJE |
40 | |||||||||
| Actual Study Completion Date ICMJE | February 20, 2019 | |||||||||
| Actual Primary Completion Date | February 20, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 50 Years (Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Egypt | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT03922295 | |||||||||
| Other Study ID Numbers ICMJE | 1ORL | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Noha A.Elkholy, Mansoura University | |||||||||
| Study Sponsor ICMJE | Mansoura University | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Mansoura University | |||||||||
| Verification Date | September 2019 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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