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Tympanoplasty Using Conchal Cavum Approach and Conchal Pericondrium

Primary Purpose

Perforation of Eardrum.

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
tympanoplasty -- conchal cavum approach
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perforation of Eardrum. focused on measuring perforation, tympanoplasty, conchal cavum approach, perichondrium/ cartilage, scar

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with informed consent

Exclusion Criteria:

  • Patients without consent

Sites / Locations

  • Christopher Man

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

perichondrium graft perforation

Arm Description

tympanoplasty -- conchal cavum approach is used.

Outcomes

Primary Outcome Measures

success rate of repair of eardrum

Secondary Outcome Measures

Full Information

First Posted
November 27, 2013
Last Updated
October 2, 2014
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02000843
Brief Title
Tympanoplasty Using Conchal Cavum Approach and Conchal Pericondrium
Official Title
Tympanoplasty -- Conchal Cavum Approach
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perforation of Eardrum.
Keywords
perforation, tympanoplasty, conchal cavum approach, perichondrium/ cartilage, scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
perichondrium graft perforation
Arm Type
Other
Arm Description
tympanoplasty -- conchal cavum approach is used.
Intervention Type
Procedure
Intervention Name(s)
tympanoplasty -- conchal cavum approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
success rate of repair of eardrum
Time Frame
one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with informed consent Exclusion Criteria: Patients without consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Man, MD FRCS(C)
Organizational Affiliation
UBC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christopher Man
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5N 4C4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22643445
Citation
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.
Results Reference
background
PubMed Identifier
26739478
Citation
Man SC, Nunez DA. Tympanoplasty--conchal cavum approach. J Otolaryngol Head Neck Surg. 2016 Jan 6;45:1. doi: 10.1186/s40463-015-0113-3.
Results Reference
derived

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Tympanoplasty Using Conchal Cavum Approach and Conchal Pericondrium

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