NCT00222417

Brief Summary

We study audiometric parameters including Transient Otoacoustic emissions, pure-tone audiometry for air- and bone-conduction, and spondaic speech recognition thresholds for air- and bone conduction in a pre- and postoperative situation in patients due for surgery for tympanic membrane perforations and otosclerosis. The hypotheses are that the precision of the preoperative assessment may be increased, and our knowledge about the effect on the inner ear by middle ear surgery may be increased.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 21, 2012

Status Verified

June 1, 2012

First QC Date

September 13, 2005

Last Update Submit

June 20, 2012

Conditions

OtosclerosisTympanic Membrane Perforation

Outcome Measures

Primary Outcomes (1)

  • Post-operative hearing threshold level

    Pure tone audiometry, speech audiometry, otoacoustic emissions

    1 year

Study Arms (2)

Myringoplasty

Patients subject to myringoplasty for tympanic membrane perforations.

Procedure: myringoplasty

Otosclerosis

Patients subject to stapes surgery

Procedure: Stapes surgery

Interventions

myringoplastyPROCEDURE

Myringoplasty is an operative procedure to close tympanic membrane perforations.

Myringoplasty
Stapes surgeryPROCEDURE

Operative procedure aimed to replace non-functioning stapes with a synthetic prosthesis

Otosclerosis

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sample of patients scheduled for middle ear surgery at the University Hospital North Norway in Tromsø.

You may qualify if:

  • Tympanic membrane perforation without chronic secretion or cholesteatoma
  • Suspected otosclerosis

You may not qualify if:

  • Below 12 years of age
  • Patient not consenting to study
  • Perioperative findings suggesting chronic otitis or cholesteatoma
  • Patients not fluent in Norwegian or unable to cooperate in audiometry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ENT-department, University Hospital of Tromsø

Tromsø, Troms, 9038, Norway

Location

MeSH Terms

Conditions

OtosclerosisTympanic Membrane Perforation

Interventions

MyringoplastyStapes Surgery

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Otologic Surgical ProceduresOtorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Niels C Stenklev, MD, PhD

    ENT-department, University of Tromsø, 9038 Tromsø, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

September 1, 2002

Study Completion

December 1, 2014

Last Updated

June 21, 2012

Record last verified: 2012-06

Locations

NO(1)