Mastoidectomy Followed by Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media: a Retrospective Comparative Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Diakonessenhuis, Utrecht
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- The number of patients with a dry ear at one-year postoperatively
Study Overview
Brief Summary
Chronic suppurative otitis media (CSOM) is characterized by intermittent or continuous otorrhea lasting for longer than 6 weeks. Most cases can be treated conservatively using antibiotic drops and oral antibiotics. However, some cases will not respond to conservative treatment and demonstrate persistant discharge. In these cases, especially if a CT-scan shows opacification of the mastoid air cells, a mastoidectomy can be considered as treatment modality. In recent years, obliteration of the mastoid cavity following mastoidectomy is gaining popularity. However, the effectiveness of obliterating the mastoid in comparison to mastoidectomy alone is uncertain for CSOM. In this retrospective cohort study, our aim is to compare mastoidectomy to mastoidectomy + mastoid obliteration in a cohort of patients suffering from CSOM with mastoid involvement. The hypothesis is that obliterating the mastoid cavity will result in a higher frequency of dry ears and in a lower frequency of revision surgeries.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The number of patients with a dry ear at one-year postoperatively
Time Frame: At 1-year postoperatively
The number of cases that have a dry ear at the one-year postoperative out-patient visit. A dry ear is defined as Merchant grade 0 or 1 (No otorrhea or less than one period of otorrhea in the last three months, respectively). A wet ear, thus suffering from otorrhea, is defined as merchant grade 2 or 3 (intermittent more than once in last three months or continuous discharge, respectively). We compare the obliteration cohort to the non-obliteration cohort.
Secondary Outcomes
- The number of cases with perforations of the tympanic membrane during follow-up(Measured at 1-year postoperatively and 3-years postoperatively)
- The number of cases which require revision surgery during follow-up(Measured at 3-years and 5-years postoperatively)
- The difference in air conduction postoperatively(First audiometry postoperatively, which is made at 6 months postoperatively)