Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media (CSOM) Without Posterior Meatal Flap

NCT ID: NCT05086718

Last Updated: 2021-10-21

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-09-30

Brief Summary

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Composite Cartilage Perichondrium Graft for tympanoplasty in chronic suppurative otitis media (CSOM) Air Bone Gap (AB Gap) Closure will be taken as successful outcome Endoscopic technique without posterior meatal flap elevation

Detailed Description

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300 eligible cases of dry CSOM will under go Composite Cartilage Perichondrium Graft tympanoplasty. Air Bone Gap Closure will be taken as successful outcome. The procedure will employ endoscopic technique without posterior meatal flap elevation.

Conditions

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Tympanic Membrane Perforation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

300 cases of dry perforation CSOM
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AB Gap Closure

Air Bone gap closure following surgery will be considered as successful outcome

Group Type OTHER

Endoscopic ear surgery

Intervention Type OTHER

Endoscopic approach without posterior meatal flap elevation will be employed in the ear with dry chronic suppurative otitis media. Tympanoplasty utilizing composite cartilage-fascia graft will be performed. After three months of time period successful outcome will be taken as closure of air bone gap on pure tone audiometry.

Interventions

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Endoscopic ear surgery

Endoscopic approach without posterior meatal flap elevation will be employed in the ear with dry chronic suppurative otitis media. Tympanoplasty utilizing composite cartilage-fascia graft will be performed. After three months of time period successful outcome will be taken as closure of air bone gap on pure tone audiometry.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Both genders between 21 to 55 years
2. Dry chronic suppurative otitis media
3. Air bone gap between 15 to 25 Deci bel

Exclusion Criteria

1. Discharging ear
2. Pediatric population
3. Ossicular Necrosis
4. Previous ear surgery
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Combined Military Hospital Quetta

OTHER

Sponsor Role lead

Responsible Party

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Dr Zeeshan Ayub

Associate Professor ENT

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CMH Quetta

Quetta, Balochistan, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Zeeshan Ayub, FCPS

Role: CONTACT

03215233648

Facility Contacts

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Zeeshan Ayub, FCPS

Role: primary

+923215233648

Azeema Ahmed, FCPS

Role: backup

+923325222335

References

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Akyigit A, Sakallioglu O, Karlidag T. Endoscopic tympanoplasty. J Otol. 2017 Jun;12(2):62-67. doi: 10.1016/j.joto.2017.04.004. Epub 2017 Apr 28.

Reference Type RESULT
PMID: 29937839 (View on PubMed)

Other Identifiers

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RRB/531/CMH Quetta

Identifier Type: -

Identifier Source: org_study_id