Tympanoplasty Using Conchal Cavum Approach and Conchal Pericondrium

Perforation of Eardrum. Clinical Trial

Official title:

Tympanoplasty -- Conchal Cavum Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02000843
• Other study ID #: H13-03261
• Status: Completed
• Phase: N/A
• First received: November 27, 2013
• Last updated: October 2, 2014
• Start date: December 2013
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients with informed consent

Exclusion Criteria:

• Patients without consent

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perforation of Eardrum.
• Tympanic Membrane Perforation

Intervention

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.

Locations

Country	Name	City	State
Canada	Christopher Man	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Mohamad SH, Khan I, Hussain SS. Is cartilage tympanoplasty more effective than fascia tympanoplasty? A systematic review. Otol Neurotol. 2012 Jul;33(5):699-705. doi: 10.1097/MAO.0b013e318254fbc2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate of repair of eardrum		one year	No