Cost effectiveness of MRI diffusion in cholesteatoma follow-up

Cost effectiveness of follow-up with diffusion-weighted MRI versus surgical follow-up after cholesteatoma treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26889

Enrollment

153

Registered

2016-09-13

Start date

2016-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ENG: Cholesteatoma, MRI, Hearing, Cost-effectiveness, Quality of Life, QALY DUTCH: Cholesteatoom, MRI, Gehoor, Kosteneffectiviteit, Kwaliteit van Leven, QALY

Interventions

Only questionnaires will be extra for all patients Half of the patients will undergo the standard care, which is a second look surgery intervention including one day hospitalization. The other half w

Eligibility

Inclusion criteria

Inclusion criteria: • 16 years of age or older. • patients who underwent a surgical procedure (canal wall up tympanoplasty) for eradication of primary acquired or recurrent cholesteatoma • primary surgery at a maximum of 11 months prior to the start of the study. • patients with normal to mild conductive hearing loss, defined as: mean air-bone gap of less than or equal to (≤) 20dB on pure tone audiometry at frequencies of 0.5, 1 and 2 kHz or 1,2 and 4 kHz. • capable and willing to participate in a follow-up study of three years

Exclusion criteria

Exclusion criteria: • patients who underwent a canal wall down tympanoplasty procedure as last ear surgical procedure (patients with a canal wall down procedure in the last 10 months will be requested to participate in the cholesteatoma observational study) • patients with a moderate to severe average air-bone gap of more than (>) 20 dB (patients eligible for a chain reconstruction will be requested to participate in the cholesteatoma observational study) • patients not capable to undergo a MRI (claustrophobic, metal parts or implants in the body etc.)

Design outcomes

Primary

Measure	Time frame
1.The degree of hearing loss (in average air-bone gap (dB))and high and low Fletcher index in each year of follow-up after primary cholesteatoma surgery	—

Secondary

Measure	Time frame
2. The estimated costs of three years follow-up (especially in Observational CWU follow-up) 3. The outcomes of health related quality of life questionnaires (EQ-5D, OQUA, AIAHD)in each year of follow-up after primary cholesteatoma surgery. 4. The number of additional surgeries with cholesteatoma present (number of residual and recurrent cholesteatoma) 5. The number of additional surgeries without cholesteatoma to improve the hearing 6. The number and nature of the complications	—

Measure

Time frame

2. The estimated costs of three years follow-up (especially in Observational CWU follow-up) 3. The outcomes of health related quality of life questionnaires (EQ-5D, OQUA, AIAHD)in each year of follow-up after primary cholesteatoma surgery. 4. The number of additional surgeries with cholesteatoma present (number of residual and recurrent cholesteatoma) 5. The number of additional surgeries without cholesteatoma to improve the hearing 6. The number and nature of the complications

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Contacts

Public ContactPaul Merkus

Vrije Universiteit Medisch Centrum - Afd. KNO

DCD@vumc.n020-4443690

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)