NCT06691139

Brief Summary

A Comparative Study of Temporalis Fascia Graft and Periosteal Graft in Myringoplasty

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

November 1, 2024

Last Update Submit

November 13, 2024

Conditions

Myringoplasty

Outcome Measures

Primary Outcomes (1)

  • hearing improvment

    outcome of temporalis fascia graft and periosteal graft for managment tympanic membrane perforation for audiological improvement

    from January 2022 to January 2024

Study Arms (2)

Group (A) patients with periosteal graft

patients whose underwent to myringoplasty using periosteal graft

Procedure: Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia graft in patients ages from 12 years to 40 yearsOther: Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graftProcedure: Myringoplasty operation using periosteal graft and myringoplasty using Temporalis fascia graftProcedure: Group (A) myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graft

(B) patients with Temporalis fascia graft

patients whose underwent to myringoplasty using Temporalis fascia graft

Procedure: Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia graft in patients ages from 12 years to 40 yearsOther: Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graftProcedure: Myringoplasty operation using periosteal graft and myringoplasty using Temporalis fascia graftProcedure: Group (A) myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graft

Interventions

Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia graft in patients ages from 12 years to 40 yearsPROCEDURE

Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia

(B) patients with Temporalis fascia graftGroup (A) patients with periosteal graft
Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graftOTHER

Group (A) Myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graft

(B) patients with Temporalis fascia graftGroup (A) patients with periosteal graft
Myringoplasty operation using periosteal graft and myringoplasty using Temporalis fascia graftPROCEDURE

Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graft in age from 12years to 40 years

(B) patients with Temporalis fascia graftGroup (A) patients with periosteal graft
Group (A) myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graftPROCEDURE

Myringoplasty operation using Temporalis fascia graft and Myringoplasty using periosteal graft in patients from 12 years to 40 years

(B) patients with Temporalis fascia graftGroup (A) patients with periosteal graft

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Sohag university hospital

You may qualify if:

  • age 12years to 40 years Small to moderate sized perforation . Dry tubotympanic chronic suppurative otitis media For more than 6 weeks .

You may not qualify if:

  • Active discharge or superimposed otomycosis . Patients with sensorineural hearing loss. Patients with considerable nasal pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Retrospective study, charts will be reviewed for 80 patients ages from 12 years to 40 years with complete records who underwent myringoplasty by otorhinolaryngologist at sohag university hospital from January 2022 to January 2024

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • ahmed Nada

    Sohag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident, otorhinolaryngology Head and neck department sohag university

Study Record Dates

First Submitted

November 1, 2024

First Posted

November 15, 2024

Study Start

January 1, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)