Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media (CSOM) Without Posterior Meatal Flap
Primary Purpose
Tympanic Membrane Perforation
Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Endoscopic ear surgery
Sponsored by
About this trial
This is an interventional treatment trial for Tympanic Membrane Perforation
Eligibility Criteria
Inclusion Criteria:
- Both genders between 21 to 55 years
- Dry chronic suppurative otitis media
- Air bone gap between 15 to 25 Deci bel
Exclusion Criteria:
- Discharging ear
- Pediatric population
- Ossicular Necrosis
- Previous ear surgery
Sites / Locations
- CMH QuettaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
AB Gap Closure
Arm Description
Air Bone gap closure following surgery will be considered as successful outcome
Outcomes
Primary Outcome Measures
Successful air bone gap closure on pure tone audiometry
Three months of endoscopic tympanoplasty using composite cartilage-fascia graft, pure tone audiometry will be carried out measuring both air and bone conduction. Successful outcome will be closure of the air bone gap as compared with pre surgery air bone gap.
Secondary Outcome Measures
Full Information
NCT ID
NCT05086718
First Posted
September 25, 2021
Last Updated
October 7, 2021
Sponsor
Combined Military Hospital Quetta
1. Study Identification
Unique Protocol Identification Number
NCT05086718
Brief Title
Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media (CSOM) Without Posterior Meatal Flap
Official Title
Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media Without Posterior Meatal Flap
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Quetta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Composite Cartilage Perichondrium Graft for tympanoplasty in chronic suppurative otitis media (CSOM) Air Bone Gap (AB Gap) Closure will be taken as successful outcome Endoscopic technique without posterior meatal flap elevation
Detailed Description
300 eligible cases of dry CSOM will under go Composite Cartilage Perichondrium Graft tympanoplasty. Air Bone Gap Closure will be taken as successful outcome. The procedure will employ endoscopic technique without posterior meatal flap elevation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tympanic Membrane Perforation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
300 cases of dry perforation CSOM
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AB Gap Closure
Arm Type
Other
Arm Description
Air Bone gap closure following surgery will be considered as successful outcome
Intervention Type
Other
Intervention Name(s)
Endoscopic ear surgery
Intervention Description
Endoscopic approach without posterior meatal flap elevation will be employed in the ear with dry chronic suppurative otitis media. Tympanoplasty utilizing composite cartilage-fascia graft will be performed. After three months of time period successful outcome will be taken as closure of air bone gap on pure tone audiometry.
Primary Outcome Measure Information:
Title
Successful air bone gap closure on pure tone audiometry
Description
Three months of endoscopic tympanoplasty using composite cartilage-fascia graft, pure tone audiometry will be carried out measuring both air and bone conduction. Successful outcome will be closure of the air bone gap as compared with pre surgery air bone gap.
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Both genders between 21 to 55 years
Dry chronic suppurative otitis media
Air bone gap between 15 to 25 Deci bel
Exclusion Criteria:
Discharging ear
Pediatric population
Ossicular Necrosis
Previous ear surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeeshan Ayub, FCPS
Phone
03215233648
Email
zeeshanent@yahoo.com
Facility Information:
Facility Name
CMH Quetta
City
Quetta
State/Province
Balochistan
ZIP/Postal Code
87300
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeeshan Ayub, FCPS
Phone
+923215233648
Email
zeeshanent@yahoo.com
First Name & Middle Initial & Last Name & Degree
Azeema Ahmed, FCPS
Phone
+923325222335
Email
azeemazeeshan1980@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
It will depend upon study outcome
Citations:
PubMed Identifier
29937839
Citation
Akyigit A, Sakallioglu O, Karlidag T. Endoscopic tympanoplasty. J Otol. 2017 Jun;12(2):62-67. doi: 10.1016/j.joto.2017.04.004. Epub 2017 Apr 28.
Results Reference
result
Learn more about this trial
Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media (CSOM) Without Posterior Meatal Flap
We'll reach out to this number within 24 hrs