NCT05086718

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

September 25, 2021

Last Update Submit

October 7, 2021

Conditions

Tympanic Membrane Perforation

Outcome Measures

Primary Outcomes (1)

  • Successful air bone gap closure on pure tone audiometry

    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.

    Three months

Study Arms (1)

AB Gap Closure

OTHER

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

Other: Endoscopic ear surgery

Interventions

Endoscopic ear surgeryOTHER

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.

AB Gap Closure

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders between 21 to 55 years
  • Dry chronic suppurative otitis media
  • Air bone gap between 15 to 25 Deci bel

You may not qualify if:

  • Discharging ear
  • Pediatric population
  • Ossicular Necrosis
  • Previous ear surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMH Quetta

Quetta, Balochistan, 87300, Pakistan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29937839RESULT

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesWounds and Injuries

Central Study Contacts

Zeeshan Ayub, FCPS

CONTACT

03215233648zeeshanent@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 300 cases of dry perforation CSOM
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor ENT

Study Record Dates

First Submitted

September 25, 2021

First Posted

October 21, 2021

Study Start

September 1, 2021

Primary Completion

August 31, 2022

Study Completion

September 30, 2022

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations

PA(1)