Tympanic Membrane PerforationNCT05086718
Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media (CSOM) Without Posterior Meatal Flap
A study testing Endoscopic ear surgery in people with Tympanic Membrane Perforation, run by Combined Military Hospital Quetta at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Endoscopic ear surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both genders between 21 to 55 years
- Dry chronic suppurative otitis media
- Air bone gap between 15 to 25 Deci bel
Who cannot join
- Discharging ear
- Pediatric population
- Ossicular Necrosis
- Previous ear surgery
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
CMH Quetta
Quetta, Balochistan, 87300
Zeeshan Ayub, FCPS, +923215233648, zeeshanent@yahoo.com
Azeema Ahmed, FCPS, +923325222335, azeemazeeshan1980@gmail.com
About this study
Official title: Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media Without Posterior Meatal Flap
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
Read the 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.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Endoscopic ear surgery
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| AB Gap Closure | Other | Air Bone gap closure following surgery will be considered as successful outcome Receives: Other: Endoscopic ear surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Sep 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 300 cases of dry perforation CSOM
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Quetta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Zeeshan Ayub, Combined Military Hospital Quetta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086718
- Sponsor's protocol ID
- RRB/531/CMH Quetta
- Status last verified
- Oct 2021
- First submitted
- 25 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will depend upon study outcome
Publications
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.
PubMed 29937839
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media Without Posterior Meatal Flap
- ClinicalTrials.gov ID
- NCT05086718
- Acronym / sponsor ID
- RRB/531/CMH Quetta
- Conditions
- Tympanic Membrane Perforation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Combined Military Hospital QuettaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 300 cases of dry perforation CSOM
| Arm | Type | Receives |
|---|---|---|
| AB Gap Closure | Other | Other: Endoscopic ear surgeryAir Bone gap closure following surgery will be considered as successful outcome |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both genders between 21 to 55 years
- Dry chronic suppurative otitis media
- Air bone gap between 15 to 25 Deci bel
Key exclusion criteria (4 listed)
- Discharging ear
- Pediatric population
- Ossicular Necrosis
- Previous ear surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ear surgeryEndoscopic 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. | Other | AB Gap Closure |
Primary outcome
Successful air bone gap closure on pure tone audiometry
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Results publication: PubMed 29937839Akyigit 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.
- Individual participant dataSharing planned: Undecided. It will depend upon study outcome
Related trials for Tympanic Membrane Perforation
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
Not yet recruiting
Effectiveness of Silver Nitrate Cauterization vs Conservative Management in Tympanic Membrane Perforation Closure
Tympanic Membrane Perforation
Not yet recruiting
Does Adding a Fascial Layer to the Cartilage in Tympanoplasty for Large Tympanic Membrane Perforation Affect the Overall Results?
Tympanic Membrane Perforation, Otitis Media
Not yet recruiting
Boomerang-Shaped Cartilage Graft in Endoscopic Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ear surgery in people with Tympanic Membrane Perforation, run by Combined Military Hospital Quetta at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeeshan Ayub, FCPS (03215233648, zeeshanent@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful air bone gap closure on pure tone audiometry (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05086718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.