Tragal Perichondrium Versus Pretragal Fascial (SMAS) Graft for Endoscopic Myringoplasty
The Tragal Perichondrium Versus the Pretragal Fascial Grafts for Endoscopic Myringoplasty: Comparative Study
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
- 1.Examine the treatment outcomes of the pretragal (SMAS) fascia as a new graft when used in endoscopic myringoplasty.
- 2.Compare the results when using the tragal pericondrium as a graft in endoscopic myringoplasty regarding donor site and success.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2020
CompletedFirst Posted
Study publicly available on registry
December 29, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedJanuary 5, 2021
November 1, 2020
1.7 years
September 26, 2020
January 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
comparison of tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty
comparison of results when using tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty success rate by audiological evaluation by using audiotympanogram
Baseline
Study Arms (2)
Tragal preichondrium graft
ACTIVE COMPARATORTragal perichodrium graft for endoscopic myringoplasty as a reference graft
pretragal ( SMAS) fascia graft
ACTIVE COMPARATORpretragal ( SMAS) fascia graft for endoscopic myringoplasty as a new graft
Interventions
Endoscopic myringoplasty by using two different grafts one each time
Eligibility Criteria
You may qualify if:
- Above 16 yrs old and less than 50 yrs old.
- Clinically diagnosed central tympanic membrane perforations or chronic suppurative otitis media (tubo-tympanic).
- Dry ear: no otorrhea without medication for at least 1 month.
- Hearing loss gap not more than 50dB
You may not qualify if:
- Age less than 16 or more than 50.
- Discharging (active) central perforations.
- Unsafe CSOM with cholesteatoma.
- Suspected ossicular pathology in safe CSOM if the gap \> 50dB.
- Previous ear surgery.
- Patients unfit for surgery or having chronic medical illness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Lin MY, Chang TS, Liao JB. The Pretragal Superficial Musculoaponeurotic System Fascia: A New Graft Material for Transcanal Tympanoplasty. Otol Neurotol. 2020 Jun;41(5):644-653. doi: 10.1097/MAO.0000000000002599.
PMID: 32080032BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident doctor in otolaryngology
Study Record Dates
First Submitted
September 26, 2020
First Posted
December 29, 2020
Study Start
January 1, 2021
Primary Completion
October 1, 2022
Study Completion
November 1, 2022
Last Updated
January 5, 2021
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share