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

Primary Purpose

Tympanic Membrane Perforation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopic myringoplasty
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tympanic Membrane Perforation

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Tragal preichondrium graft

    pretragal ( SMAS) fascia graft

    Arm Description

    Tragal perichodrium graft for endoscopic myringoplasty as a reference graft

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 26, 2020
    Last Updated
    January 1, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04687995
    Brief Title
    Tragal Perichondrium Versus Pretragal Fascial (SMAS) Graft for Endoscopic Myringoplasty
    Official Title
    The Tragal Perichondrium Versus the Pretragal Fascial Grafts for Endoscopic Myringoplasty: Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    November 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Examine the treatment outcomes of the pretragal (SMAS) fascia as a new graft when used in endoscopic myringoplasty. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tympanic Membrane Perforation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tragal preichondrium graft
    Arm Type
    Active Comparator
    Arm Description
    Tragal perichodrium graft for endoscopic myringoplasty as a reference graft
    Arm Title
    pretragal ( SMAS) fascia graft
    Arm Type
    Active Comparator
    Arm Description
    pretragal ( SMAS) fascia graft for endoscopic myringoplasty as a new graft
    Intervention Type
    Procedure
    Intervention Name(s)
    Endoscopic myringoplasty
    Intervention Description
    Endoscopic myringoplasty by using two different grafts one each time
    Primary Outcome Measure Information:
    Title
    comparison of tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Above 16 yrs old and less than 50 yrs old. Clinically diagnosed central tympanic membrane perforations or chronic suppurative otitis media (tubo-tympanic). Dry ear: no otorrhea without medication for at least 1 month. Hearing loss gap not more than 50dB Exclusion Criteria: Age less than 16 or more than 50. Discharging (active) central perforations. Unsafe CSOM with cholesteatoma. Suspected ossicular pathology in safe CSOM if the gap > 50dB. Previous ear surgery. Patients unfit for surgery or having chronic medical illness.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hazem Gamal Noreldin, Resident
    Phone
    01024806122
    Email
    hazzmnoreldin@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mahmoud Mohamed Ragheb, Professor
    Phone
    01003317723
    Email
    mahmoud.elsherief@med.au.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32080032
    Citation
    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.
    Results Reference
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    Tragal Perichondrium Versus Pretragal Fascial (SMAS) Graft for Endoscopic Myringoplasty

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