Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media

Recruiting

• Conditions: Chronic Suppurative Otitis Media
• Interventions: Device: S53P4 Bioactive glass

• Registration Number: NCT06160505
• Lead Sponsor: Diakonessenhuis, Utrecht

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Study First Posted: 2023-12-07
• Last Update Posted: 2023-12-07
• Primary Completion: 2024-04-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients that underwent mastoidectomy + mastoid obliteration	S53P4 Bioactive glass	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

Primary Outcome Measures

Name	Time	Method
The number of patients with a dry ear at one-year postoperatively	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 Outcome Measures

Name	Time	Method
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 that will develop a perforation of the tympanic membrane during follow-up; We compare the obliteration cohort to the non-obliteration cohort.
The number of cases which require revision surgery during follow-up	Measured at 3-years and 5-years postoperatively	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.
The difference in air conduction postoperatively	First audiometry postoperatively, which is made at 6 months 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.

Trial Locations

Locations (1)

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands