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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tympanic Membrane Perforation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tragal preichondrium graft

Tragal perichodrium graft for endoscopic myringoplasty as a reference graft

Group Type ACTIVE_COMPARATOR

Endoscopic myringoplasty

Intervention Type PROCEDURE

Endoscopic myringoplasty by using two different grafts one each time

pretragal ( SMAS) fascia graft

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

Group Type ACTIVE_COMPARATOR

Endoscopic myringoplasty

Intervention Type PROCEDURE

Endoscopic myringoplasty by using two different grafts one each time

Interventions

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Endoscopic myringoplasty

Endoscopic myringoplasty by using two different grafts one each time

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No