Tympanoplasty Using Conchal Cavum Approach and Conchal Pericondrium

October 2, 2014 updated by: University of British Columbia

Tympanoplasty -- Conchal Cavum Approach

Tympanoplasty -- conchal cavum approach is a modification of Heermann endural approach to repair broken eardrums. The Heermann approach is a well recognized procedure, in common clinical practise for years.

The new approach has been used in patients after informed consent was obtained from each patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From 2010 to 2013, a total of 96 patients had the procedure. The data are entered, and analyzed. All identifiable information would be hidden.

This application is to obtain patients' consent for release and publication of the data. Patients would be assured their identities are protected.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5N 4C4
        • Christopher Man

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients with informed consent

Exclusion Criteria:

  • Patients without consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: perichondrium graft perforation
tympanoplasty -- conchal cavum approach is used.
Procedure: tympanoplasty -- conchal cavum approach
Incision is made inside the ear canal. It is extended into the conchal cavum. The incision allows a direct approach to the eardrum, and also allow easy harvesting of the perichondrium to be used as graft material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
success rate of repair of eardrum
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Christopher Man, MD FRCS(C), UBC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

October 3, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-03261

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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