Tragal Perichondrium Versus Pretragal Fascial (SMAS) Graft for Endoscopic Myringoplasty

The Tragal Perichondrium Versus the Pretragal Fascial Grafts for Endoscopic Myringoplasty: Comparative Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04687995

Enrollment

Registered

2020-12-29

Start date

2021-01-31

Completion date

2022-11-30

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tympanic Membrane Perforation

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.

Detailed description

The exclusive transcanal endoscopic tympanoplasty technique emerged in the1990s : it provides a more direct and wider surgical viewing angle, largely reduces the necessity for a traumatic postauricular incision. Some otolgists have adopted this technique using the nearby tragal perichondrium/cartilage graft. The tragus has a pivotal function in reconstruction in ear surgery. The superficial musculoaponeurotic system (SMAS) was first introduced by Mits and Peyroniein1976. It is located in the mid-face overlying the parotid gland and mimic muscles, It connects the dermis and the muscles, acting as a unique motor unit to produce facial expressions. The SMAS graft has great potential because it is accessible from the least invasive transcanal route of tympanoplasty, and is located away from the vital structures.

Interventions

PROCEDUREEndoscopic myringoplasty

Endoscopic myringoplasty by using two different grafts one each time

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 50 Years

Healthy volunteers

Inclusion criteria

1. Above 16 yrs old and less than 50 yrs old. 2. Clinically diagnosed central tympanic membrane perforations or chronic suppurative otitis media (tubo-tympanic). 3. Dry ear: no otorrhea without medication for at least 1 month. 4. Hearing loss gap not more than 50dB

Exclusion criteria

1. Age less than 16 or more than 50. 2. Discharging (active) central perforations. 3. Unsafe CSOM with cholesteatoma. 4. Suspected ossicular pathology in safe CSOM if the gap \> 50dB. 5. Previous ear surgery. 6. Patients unfit for surgery or having chronic medical illness.

Design outcomes

Primary

Measure	Time frame	Description
comparison of tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty	Baseline	comparison of results when using tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty success rate by audiological evaluation by using audiotympanogram

Contacts

Primary ContactHazem Gamal Noreldin, Resident

hazzmnoreldin@gmail.com01024806122

Backup ContactMahmoud Mohamed Ragheb, Professor

mahmoud.elsherief@med.au.edu.eg01003317723

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026