Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Vestibular Schwannoma Vestibular Function Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups of patients, one group prehabituated by chemical labyrintectomy, the second control group without prehabituation before the surgery

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ITG (intratympanic gentamicin) group

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

Group Type EXPERIMENTAL

intratympanic application of gentamicin

Intervention Type PROCEDURE

under local anesthesia is gentamicin instilled through tympanic membrane to tympanic cavity

microsurgical removal of vestibular schwannoma

Intervention Type PROCEDURE

surgery under general anesthesia

control group

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

Group Type ACTIVE_COMPARATOR

microsurgical removal of vestibular schwannoma

Intervention Type PROCEDURE

surgery under general anesthesia

Interventions

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intratympanic application of gentamicin

under local anesthesia is gentamicin instilled through tympanic membrane to tympanic cavity

Intervention Type PROCEDURE

microsurgical removal of vestibular schwannoma

surgery under general anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Balatkova Zuzana

Zuzana Balatkova, M.D., Principal Investigator, Department of otorhinolaryngology and head and neck surgery,1st faculty of medicine Charles university and University hospital Motol, Prague, Head: Prof. Jan Plzak, M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR