Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery

Sponsor

Charles University, Czech Republic (Other)

Overall Status

Completed

CT.gov ID

NCT03638310

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vestibular Schwannoma Vestibular Function Disorder	Procedure: intratympanic application of gentamicin Procedure: microsurgical removal of vestibular schwannoma	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Assessment of Visual Sensitivity, Psychiatric Profile and Quality of Life Following Vestibular Schwannoma Surgery in Patients Prehabituated by Chemical Vestibular Ablation

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: intratympanic application of gentamicin under local anesthesia is gentamicin instilled through tympanic membrane to tympanic cavity Procedure: microsurgical removal of vestibular schwannoma surgery under general anesthesia
Active Comparator: control group patients without prehabituation before surgery. They underwent microsurgical removal of vest. schwannoma.	Procedure: microsurgical removal of vestibular schwannoma surgery under general anesthesia

Arm

Intervention/Treatment

Experimental: 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.

Procedure: intratympanic application of gentamicin

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

Procedure: microsurgical removal of vestibular schwannoma

surgery under general anesthesia

Active Comparator: control group

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

Procedure: microsurgical removal of vestibular schwannoma

surgery under general anesthesia

Outcome Measures

Primary Outcome Measures

change of optokinetic nystagmus measurement [change of the gain of optokinetic nystagmus among 3 time points is measured: before intervention, 1 week after intervention, 3 months after intervention]
During electronystagmography gain of optokinetic nystagmus is measured before and after the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charles University	Prague		Czechia	150 06

Sponsors and Collaborators

Charles University, Czech Republic

Investigators

Study Chair: Zdeněk čada, M.D., Ph.D., Charles university Prague

Study Documents (Full-Text)

None provided.

More Information

Publications

Čada Z, Balatková Z, Chovanec M, Čakrt O, Hrubá S, Jeřábek J, Zvěřina E, Profant O, Fík Z, Komarc M, Betka J, Kluh J, Černý R. Vertigo Perception and Quality of Life in Patients after Surgical Treatment of Vestibular Schwannoma with Pretreatment Prehabituation by Chemical Vestibular Ablation. Biomed Res Int. 2016;2016:6767216. doi: 10.1155/2016/6767216. Epub 2016 Dec 8.

Responsible Party:

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., Charles University, Czech Republic

ClinicalTrials.gov Identifier:

NCT03638310

Other Study ID Numbers: