An observational study in Chronic Suppurative Otitis Media, sponsored by Diakonessenhuis, Utrecht. Recruiting at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2023-12-07.
Sponsored by Diakonessenhuis, Utrecht · Observational
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.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's planned enrollment of 250 is above the median of 150 across 57 observational studies indexed under Otitis Media.
Browse Otitis Media studies →Diakonessenhuis, Utrecht is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients that underwent canal wall up or canal wall down mastoidectomy between 2010 and 2022 will be evaluated. Only cases that full-fill the in- and exclusion criteria will be selected. Patients will be stratified for whether they received mastoid obliteration or not.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This is the control group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy for CSOM without mastoid obliteration
This is the intervention group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy for CSOM followed by obliteration of the mastoid cavity using S53P4 bioactive glass
Device: S53P4 Bioactive glass
Following mastoidectomy, the mastoid cavity, and if the ossicular chain has been removed the epitympanum as well, are obliterated using S53P4 bioactive glass. The bioactive glass is mixed with saline and administered to the cavity, ensuring a tight fit.
The number of patients with a dry ear at one-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.
Time frame: At 1-year postoperatively
The number of cases with perforations of the tympanic membrane during follow-up
The number of cases that will develop a perforation of the tympanic membrane during follow-up We compare the obliteration cohort to the non-obliteration cohort.
Time frame: Measured at 1-year postoperatively and 3-years postoperatively
The difference in air conduction postoperatively
The differences in air conduction postoperatively, as measured in the first audiometry postoperatively in decibel. We compare the obliteration cohort to the non-obliteration cohort.
Time frame: First audiometry postoperatively, which is made at 6 months postoperatively
The number of cases which require revision surgery during follow-up
The number of cases which require revision surgery during follow-up, for either recurrent CSOM and other indications We compare the obliteration cohort to the non-obliteration cohort.
Time frame: Measured at 3-years and 5-years postoperatively
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Diakonessenhuis, Utrecht