Comparing mastoid obliteration with mastoidectomy for chronic ear infections
Mastoidectomy Followed by Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media: a Retrospective Comparative Study
This study is testing whether adding a special type of glass to ear surgery helps people with chronic ear infections have drier ears and need fewer follow-up surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Sex | All |
| Sponsor | Diakonessenhuis, Utrecht Academic / other |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT06160505 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the outcomes of mastoidectomy alone versus mastoidectomy combined with S53P4 bioactive glass obliteration in patients suffering from chronic suppurative otitis media (CSOM) with mastoid involvement. The study will analyze the frequency of dry ears and the need for revision surgeries in patients who underwent these procedures. By examining a cohort of patients operated on between 2010 and 2022, the researchers hope to determine the effectiveness of mastoid obliteration in improving patient outcomes. The study will utilize retrospective data to assess the long-term results of these surgical interventions.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with chronic suppurative otitis media who have opacification of the mastoid air cells and have undergone mastoidectomy between 2010 and 2022.
Not a fit: Patients with middle ear cholesteatoma will not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with chronic ear infections, potentially reducing the need for additional surgeries.
How similar studies have performed: While the effectiveness of mastoid obliteration is gaining interest, this specific comparison has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Suffering from CSOM, as indicated by otorrhea as main complaint preoperatively * At least one year of follow-up, in order to asses the primary outcome * Opacification of the mastoid air cells on preoperative CT-scans, as indication for mastoid involvement * Canal wall up or canal wall down mastoidectomy * Operated between 2010 and 2022 Exclusion Criteria: * Patients suffering from middle ear cholesteatoma
Where this trial is running
Utrecht
- Diakonessenhuis — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: J.J. Quak, MD, PhD — Diakonessenhuis, Utrecht
- Study coordinator: Leij-Halfwerk, Msc, Ir
- Email: Wetenschapsbureau@diakhuis.nl
- Phone: 0882506172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.