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

Not Applicable

• Conditions: Tympanic Membrane Perforation
• Interventions: Other: Endoscopic ear surgery

• Registration Number: NCT05086718
• Lead Sponsor: Combined Military Hospital Quetta

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-25
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-07
• Last Update Submitted: 2021-10-07
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21
• Primary Completion: 2022-08-31
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AB Gap Closure	Endoscopic ear surgery	Air Bone gap closure following surgery will be considered as successful outcome

Primary Outcome Measures

Name	Time	Method
Successful air bone gap closure on pure tone audiometry	Three months	Three months of endoscopic tympanoplasty using composite cartilage-fascia graft, pure tone audiometry will be carried out measuring both air and bone conduction. Successful outcome will be closure of the air bone gap as compared with pre surgery air bone gap.

Trial Locations

Locations (1)

CMH Quetta; 🇵🇰 Quetta, Balochistan, Pakistan