Clinical trial NCT03958006: Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma
Official title: Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Schwannoma
Cochlear Implantation
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.

Detailed description: This is prospective study patients undergoing a translabyrinthine resection for a vestibular schwannoma with intact hearing in the contralateral ear. During surgery, simultaneous cochlear implantation will be performed if the cochlear nerve can be identified and preserved during the resection.

Relevant data to be collected will include patient demographics, details related to the vestibular schwannoma including side, size, symptoms (specifically pre-operative hearing loss, degree of tinnitus), and status of hearing in the contralateral ear. Surgical details to be recorded will include date of surgery, surgical time, and whether the cochlear nerve was identified and preserved. Details related to the post-operative course to be recorded include length of stay in the hospital, post-operative complications such as wound infection or cerebral spinal fluid (CSF) leak, and need for revision or additional procedures.

Eligibility criteria: Inclusion Criteria:

* Patients with a vestibular schwannoma undergoing a translabyrinthine resection with intact hearing in the contralateral ear

Exclusion Criteria:

-

Primary outcomes:
measure: Measurement of Hearing Parameters
timeFrame: 1 month, 3 months and 6 months postoperatively.
measure: Measurement of Hearing Parameters
timeFrame: 1 month, 3 months and 6 months postoperatively.
measure: Measurement of Hearing Parameters
timeFrame: 1 month, 3 months and 6 months postoperatively.
Secondary outcomes:
measure: Measurement of Change of Physical Symptoms Associated with Hearing Loss
timeFrame: 1, 3 and 6 months postoperatively
measure: Assessment of Change of Physical Symptoms Associated with Hearing Loss
timeFrame: 1, 3 and 6 months postoperatively
measure: Assessment of incision site healing
timeFrame: 1 week, and 1 and 3 months postoperatively
Other outcomes:
Locations:
city: Farmington Hills
country: United States
facility: Seilesh Babu
state: Michigan
Study officials:
affiliation: Michigan Ear Institute, Farmington Hills, MI
name: Seilish Babu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dos Santos Neto PH, Zamponi JO, Hamerschmidt R, Wiemes GRM, Rassi MS, Borba LAB. Simultaneous cochlear implantation as a therapeutic option in vestibular schwannoma surgery: case report. Neurosurg Focus. 2018 Mar;44(3):E9. doi: 10.3171/2017.12.FOCUS17670.
citation: Lloyd SK, Glynn FJ, Rutherford SA, King AT, Mawman DJ, O'Driscoll MP, Evans DG, Ramsden RT, Freeman SR. Ipsilateral cochlear implantation after cochlear nerve preserving vestibular schwannoma surgery in patients with neurofibromatosis type 2. Otol Neurotol. 2014 Jan;35(1):43-51. doi: 10.1097/MAO.0000000000000185.
citation: Bohr C, Muller S, Hornung J, Hoppe U, Iro H. [Hearing restoration with cochlear implants after translabyrinthine vestibular schwannoma resection]. HNO. 2017 Sep;65(9):758-765. doi: 10.1007/s00106-017-0404-2. German.
citation: Hassepass F, Arndt S, Aschendorff A, Laszig R, Wesarg T. Cochlear implantation for hearing rehabilitation in single-sided deafness after translabyrinthine vestibular schwannoma surgery. Eur Arch Otorhinolaryngol. 2016 Sep;273(9):2373-83. doi: 10.1007/s00405-015-3801-8. Epub 2015 Oct 23.
citation: DeHart AN, Broaddus WC, Coelho DH. Translabyrinthine vestibular schwannoma resection with simultaneous cochlear implantation. Cochlear Implants Int. 2017 Sep;18(5):278-284. doi: 10.1080/14670100.2017.1337665. Epub 2017 Jun 12.
citation: Sanna M, Medina MD, Macak A, Rossi G, Sozzi V, Prasad SC. Vestibular Schwannoma Resection with Ipsilateral Simultaneous Cochlear Implantation in Patients with Normal Contralateral Hearing. Audiol Neurootol. 2016;21(5):286-295. doi: 10.1159/000448583. Epub 2016 Nov 5.
citation: Rooth MA, Dillon MT, Brown KD. Prospective Evaluation of Patients Undergoing Translabyrinthine Excision of Vestibular Schwannoma with Concurrent Cochlear Implantation. Otol Neurotol. 2017 Dec;38(10):1512-1516. doi: 10.1097/MAO.0000000000001570.