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

Tympanic Membrane Perforation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04687995
• Other study ID #: Endoscopic myringoplasty
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: November 2022

Study information

• Verified date: November 2020
• Source: Assiut University
• Contact: Hazem Gamal Noreldin, Resident
• Phone: 01024806122
• Email: hazzmnoreldin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tympanic Membrane Perforation

Intervention

Procedure:
• Endoscopic myringoplasty
Endoscopic myringoplasty by using two different grafts one each time

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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