Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery

Charles University, Czech Republic

Status: Completed

Conditions: Vestibular Function Disorder; Vestibular Schwannoma

Treatments: Procedure: microsurgical removal of vestibular schwannoma; Procedure: intratympanic application of gentamicin

Study type: Interventional

Funder types: Other

Identifiers

NCT03638310

13943 FN Motol

Details and patient eligibility

About

The aim of this study is to assess effect of psychiatric profile on visual sensitivity and overall health status in patients who underwent surgery for vestibular schwannoma and were prehabituated by chemical vestibular ablation.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• T3, T4 vestibular schwannoma
• recorded growth of a tumour
• hearing loss greater than 50% in PTA

Exclusion criteria

• T1 vestibular schwannomas
• no growth progression
• normal hearing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

ITG (intratympanic gentamicin) group

Experimental group

Description:

Patients who underwent prehabituation by gentamicin prior to surgery for vestibular schwannoma. They underwent intratympanic application of gentamicin and microsurgical removal of vest. schwannoma.

Treatment:

Procedure: intratympanic application of gentamicin

Procedure: microsurgical removal of vestibular schwannoma

control group

Active Comparator group

Description:

patients without prehabituation before surgery. They underwent microsurgical removal of vest. schwannoma.

Treatment:

Procedure: microsurgical removal of vestibular schwannoma