Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | ChoLEsteatomA Recidivism – Evaluation And Recommendations |
| Participants (P) | Patients above the age of 18 who undergo a canal wall up (CWU) approach for removal of cholesteatoma in one of the participating centres. |
| Intervention (I) | Patients will have a CWU approach with obliteration. |
| Control (C) | Patients will undergo a CWU approach without obliteration |
| Outcome (O) | The primary aim of this randomized controlled trial is to determine whether CWU tympanomastoidectomy with obliteration reduces the recurrence and residual rates of cholesteatoma compared to CWU tympanomastoidectomy without obliteration. |
| Trial Design | The proposed study is a single-blind randomized trial. Patients are randomized into one of two groups in an equal 1:1 allocation ratio. |
| Sample Size | 178 (71 in Belgium) |
| Trial duration | 84 months |
| Budget | 434.000€ |
Trial team
| Sponsor | UMC Utrecht BCC: UZ Leuven |
| Chief Investigator | Prof. Dr. Thomeer |
| BCC Investigator | Prof. Dr. Verhaert (UZ Leuven) |
| Number of participating sites | 3 |
DOCUMENTS
References
Clinicaltrials.gov:
Webpage:
Funding scheme
