Trials / Completed
CompletedNCT03922295
Endoscopic Tympanoplasty: Single Versus Double Flap Technique
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Mansoura University · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-08-24
- Primary completion
- 2019-02-20
- Completion
- 2019-02-20
- First posted
- 2019-04-19
- Last updated
- 2019-09-10
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT03922295. Inclusion in this directory is not an endorsement.