Mastoidectomy Followed by Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media: a Retrospective Comparative Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Diakonessenhuis
RECRUITING
Utrecht
Contact Information
Primary
Leij-Halfwerk, Msc, Ir
Wetenschapsbureau@diakhuis.nl
0882506172
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2024-06-01
Participants
Target number of participants: 250
Treatments
Patients that underwent mastoidectomy alone
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
Patients that underwent mastoidectomy + 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
Related Therapeutic Areas
Sponsors
Leads: Diakonessenhuis, Utrecht

This content was sourced from clinicaltrials.gov