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

Assiut University

Status: Unknown

Conditions: Tympanic Membrane Perforation

Treatments: Procedure: Endoscopic myringoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04687995

Endoscopic myringoplasty

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Tragal preichondrium graft

Active Comparator group

Description:

Tragal perichodrium graft for endoscopic myringoplasty as a reference graft

Treatment:

Procedure: Endoscopic myringoplasty

pretragal ( SMAS) fascia graft

Active Comparator group

Description:

pretragal ( SMAS) fascia graft for endoscopic myringoplasty as a new graft

Treatment:

Procedure: Endoscopic myringoplasty