Cholesteatoma, a condition in which skin cells abnormally accumulate in the middle ear and/or mastoid, can lead to hearing loss, balance disorders, recurrent infections and, in some cases, serious complications.
Surgical removal is the only curative treatment, but there is still considerable uncertainty about the best surgical technique. The risk of the disease recurring is high and may depend on the surgical technique used, often resulting in repeat procedures, an additional risk of hearing damage and high healthcare costs. Filling the cavity created by removal of the cholesteatoma with bone or another material (the so-called obliteration technique) appears promising in reducing the risk of recurrence, but robust scientific evidence is lacking..
With this large-scale, international study, we aim to compare two surgical techniques in a randomized trial involving 178 adult patients in Belgium and the Netherlands. We hope to demonstrate that the obliteration technique lowers recurrence rates, improves ear hygiene, and is cost-effective. A broader adoption of this technique would lead to fewer revision surgeries, improving care and reducing the burden for patients and society.
| 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€ |
| Sponsor | UMC Utrecht BCC: UZ Leuven |
| Chief Investigator | Prof. Dr. Thomeer |
| BCC Investigator | Prof. Dr. Verhaert (UZ Leuven) |
| Number of participating sites | 3 |
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