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Status unknownNCT04687995Updated Jan 5, 2021

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

An interventional study of Endoscopic myringoplasty in Tympanic Membrane Perforation, sponsored by Assiut University. Status unknown. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-01-05.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
16 Years to 50 Years
Sex
All
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Study 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.
Read the 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.

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Conditions studied

  • Tympanic Membrane Perforation
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In context

Tympanic Membrane Perforation

45 studies on the registry are indexed under Tympanic Membrane Perforation; 10 are open to participants now.

This study's planned enrollment of 40 is below the median of 57 across 31 interventional studies indexed under Tympanic Membrane Perforation.

Browse Tympanic Membrane Perforation studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Tragal preichondrium graft

    Tragal perichodrium graft for endoscopic myringoplasty as a reference graft

    Procedure: Endoscopic myringoplasty

  • Active comparator
    pretragal ( SMAS) fascia graft

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

    Procedure: Endoscopic myringoplasty

Interventions

  • ProcedureEndoscopic myringoplasty

    Endoscopic myringoplasty by using two different grafts one each time

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 32080032 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04687995
Lead sponsor
Assiut University
Responsible party
Hazem Gamal Noreldein (Resident doctor in otolaryngology, Assiut University) — Principal investigator
First posted
Dec 29, 2020
Start date
Jan 2021 (estimated)
Primary completion
Oct 2022 (estimated)
Completion
Nov 2022 (estimated)
Last update
Jan 5, 2021

Study contacts

Hazem Gamal Noreldin, Resident
Contact
hazzmnoreldin@gmail.com
01024806122
Mahmoud Mohamed Ragheb, Professor
Contact
mahmoud.elsherief@med.au.edu.eg
01003317723

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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