Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation '' Comparative Study ''
1 other identifier
observational
26
0 countries
N/A
Brief Summary
Use of Cartilage Versus Temporalis Fascia as a Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2022
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
March 8, 2022
CompletedFirst Posted
Study publicly available on registry
March 16, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedMarch 16, 2022
March 1, 2022
1 year
March 8, 2022
March 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Cartilage Versus Temporalis Fascia Graft in Tympanoplasty for Recurrent Tympanic Membrane Perforation '' Comparative Study ''
compare of improvment of hearing by using temporalis fascia versus cartilage tympanoplasty in recurrent perforation compare of graft take up by using temporalis fascia versus cartilage tympanoplasty in recurrent perforation
Baseline
Study Arms (2)
cartilage tympanoplasty
use cartilage in tympanoplasty for recuurent perforation
temporalis fascia graft in tympanoplasty
use temporalis fascia as a graft in tympanoplasty for recuurent perforation
Interventions
use of cartilage versus tempotalis fascia in tympanoplasty for recuurent perforation
Eligibility Criteria
Patients will be randomly divided into Group 1, where only temporalis fascia alone will be used as a graft and Group 2, where cartilage will be used along with temporalis fascia graft. Patients will be followed up and examined at 2 and 6 month to assess 1. graft take up (healing) 2. pure tone audiometry( hearing )
You may qualify if:
- patients with safe chronic suppurative otitis media patient with recurrent perforation patirnt with coductive hearing loss
You may not qualify if:
- sensorineural hearing loss active infection compromised immune system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Jalali MM, Motasaddi M, Kouhi A, Dabiri S, Soleimani R. Comparison of cartilage with temporalis fascia tympanoplasty: A meta-analysis of comparative studies. Laryngoscope. 2017 Sep;127(9):2139-2148. doi: 10.1002/lary.26451. Epub 2016 Dec 9.
PMID: 27933630BACKGROUNDShakya D, Nepal A. Long-term results of type I tympanoplasty with perichondrium reinforced cartilage palisade vs temporalis fascia for large perforations: A retrospective study. J Otol. 2021 Jan;16(1):12-17. doi: 10.1016/j.joto.2020.07.004. Epub 2020 Jul 29.
PMID: 33505444BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
hamza el shafey ahmed, doctor
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- researcher
Study Record Dates
First Submitted
March 8, 2022
First Posted
March 16, 2022
Study Start
April 1, 2022
Primary Completion
April 1, 2023
Study Completion
May 1, 2023
Last Updated
March 16, 2022
Record last verified: 2022-03