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Taste Disorders in Middle Ear Disease and After Middle Ear Surgery

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ClinicalTrials.gov Identifier: NCT01584011
Recruitment Status : Unknown
Verified April 2012 by Uppsala University.
Recruitment status was:  Recruiting
First Posted : April 24, 2012
Last Update Posted : May 8, 2012
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Tracking Information
First Submitted Date April 20, 2012
First Posted Date April 24, 2012
Last Update Posted Date May 8, 2012
Study Start Date January 2010
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2012)
Taste disturbance [ Time Frame: One year postoperative ]
Taste disturbance postoperative will be measured with electrogustometry, filter paper disc methode and symptom questionnaire before surgery and at four times after surgery up till one year poatoperative.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01584011 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 7, 2012)
  • Quality of life [ Time Frame: one year ]
    A quality of life evaluation will be performed before surgery and one year after surgery.
  • Histopathological changes [ Time Frame: At the time of surgery ]
    Electron microscopy investigation of specimen from healthy ears and from ears with chronic otitis media or cholesteatoma were the nerve could not be saved during the operation.
Original Secondary Outcome Measures
 (submitted: April 23, 2012)
  • Quality of life [ Time Frame: one year ]
    A quality of life evaluation will be performed before surgery and one year after surgery.
  • Histopathological changes [ Time Frame: after surgery ]
    Electron microscopy investigation of specimen from healthy ears and from ears with chronic otitis media or cholesteatoma were the nerve could not be saved during the operation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Taste Disorders in Middle Ear Disease and After Middle Ear Surgery
Official Title Taste Disorders in Middle Ear Disease and After Middle Ear Surgery
Brief Summary

Objectives

To evaluate the impact of taste disturbance in different types of chronic middle ear diseases and after middle ear surgery.

Hypothesis

That patients with chronic otitis media and cholesteatoma has taste disturbance already before surgery due to the disease itself, of course depending on degree of the disease.

That patients with otosclerosis, has a normal nerve function before surgery.

That patients with normal taste before surgery are more likely to notices a taste disturbance.

That nerve in continuity after surgery, even if it is maltreated, gives less taste disturbance than a divided nerve.

Methods

A clinical study has been launched that measures taste function with two different methods for taste measurements, electrogustometry (EGM) and the filter paper disc method (FPD) before and after middle ear surgery in patients operated with middle ear surgery because of otosclerosis, chronic otitis media and cholesteatoma. The investigators plan to include 120 patients in this study.

A parallel study of the patients own experience of the symptom has also been launched were the patients answer a questionary and a quality of life document. The investigators plan to include 300 patients in this study.

A histological study where specimens of CTN from healthy ears and from ears with chronic disease will be investigated with electron microscopy has also started.

Detailed Description

Taste sensations are provided by three different nerves of which the chorda tympani nerve (CTN) is the major taste nerve. It innervates taste buds in the two anterior thirds of the tongue. The CTN location in the middle ear predisposes for trauma of the nerve. In various forms of middle ear pathology, such as chronic otitis and cholesteatoma the nerve can be affected by the pathologic process per se, since the nerve may become exposed to bacteria toxins, enzymes or mechanical damage. During middle ear surgery, it can be cut off, stretched, touched or dried out by the heat of the microscope light beam. The nerve function in these situations is not clarified. Is it for example better to cut the nerve than to leave it traumatized after surgery. Therefore previous reports on objective CTN function pre- and postoperatively unfortunate suffer from inadequate descriptions of ear disease that were studied. In order to elucidate these questions and to give the surgeon deeper knowledge about how to handle CTN during surgery a prospective study is initiated on patients to be operated on with primary middle ear surgery.

We believe that patients with chronic otitis media and cholesteatoma has taste disturbance already before surgery due to the disease itself, of course depending on degree of the disease, and that patients with otosclerosis has a normal nerve function before surgery. We also believe that patients with normal taste before surgery are more likely to notice a taste disturbance and that a nerve in continuity after surgery, even if it is maltreated, gives less taste disturbance than a divided nerve. Two methods of taste measuring are used in the study, Electrogustometry (EGM) and a Filter Paper Disc method (FPD). We have evaluated EGM regarding possible bias and artifacts as well as the correlation regarding results from the two methods.

The study contains three substudies or arms.

  1. A clinical prospective trial where 100 patients that undergoes primary middle ear surgery because of chronic otitis, cholesteatoma or otosclerosis are evaluated with EGM and FPD before and after surgery. They also answer a questionnaire about subjective taste disturbance and a questionnaire about quality of life.
  2. A clinical multi center study on 200 patients that undergoes primary surgery because of otosclerosis. These patients answer a questionnaire about subjective taste disturbance and a questionnaire about quality of life.
  3. A histological study with electron microscopy of CTN from healthy ears and from ears whit chronic otitis or cholesteatoma. We we plan to investigate samples from five healthy and from five sick ears with EM.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Samples of nerve tissue
Sampling Method Non-Probability Sample
Study Population Patients planned for primary middle ear surgery due to chronic otitis media, cholesteatoma and otosclerosis
Condition Taste Disturbance
Intervention
  • Other: taste measurement
    Taste measurements with Electrogustometry and Filter paper test before and after surgery until one year after surgery
  • Other: Symptom questionnaire
    Answering a symptom questionnaire before and after surgery until one year after surgery
  • Behavioral: Quality of life questionnaire
    Answering a quality of life questionnaire before and one year after surgery
  • Other: Nerve sample
    Collect nerve samples from patients undergoing surgery because of vestibular schwannoma, chronic otitis media or cholesteatoma where the nerve cant be saved during planned operation.
Study Groups/Cohorts Middle ear disease
Interventions:
  • Other: taste measurement
  • Other: Symptom questionnaire
  • Behavioral: Quality of life questionnaire
  • Other: Nerve sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 23, 2012)
310
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients that undergoes primary middle ear surgery due to chronic otitis media, cholesteatoma and otosclerosis

Exclusion Criteria:

  • Not primary surgery
  • Not able to participate
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT01584011
Other Study ID Numbers CTN1
CTN12 ( Other Identifier: UppsalaU )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Uppsala University
Study Sponsor Uppsala University
Collaborators Not Provided
Investigators
Principal Investigator: Katarina Berling, MD 1Center for Clinical Research, County Council of Västmanland and Uppsala University, Västerås, Sweden
PRS Account Uppsala University
Verification Date April 2012