Tympanoplasty SurgeryNCT07471191
Partial Thickness vs Full Thickness Tragal Cartilage Grafts in Endoscopic Type 1 Tympanoplasty
An observational study of Tympanoplasty Surgery, run by Assiut University.
Trial summary
Primary Objective: Compare 6-month graft success rates between 0.5 mm sliced and 1.8 mm full-thickness tragal cartilage grafts.(3) H1: Sliced cartilage yields ≥90% success versus ≤80% for full-thickness.(3) H0: No difference between arms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tympanoplasty Surgery
- What is being tested?
- endoscope
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion (all required): * Age 18-65 years. * safe chronic perforation ≥6 months. * Subtotal (25-75%) or large (>75%) pars tensa defect. * Dry ear ≥3 months (culture-negative). * Intact ossicles, healthy mucosa. * Viable tragal cartilage. * Informed written consent capability. Exclusion criteria : * unsafe otitis, * active discharge, * Eustachian dysfunction e.g cleft palate, * ossicular defects * prior surgery, * unfit patients * non-compliance
Who may be able to join
- Age 18-65 years.
- safe chronic perforation ≥6 months.
- Subtotal (25-75%) or large (>75%) pars tensa defect.
- Dry ear ≥3 months (culture-negative).
- Intact ossicles, healthy mucosa.
- Viable tragal cartilage.
- Informed written consent capability.
Who cannot join
- unsafe otitis,
- active discharge,
- Eustachian dysfunction e.g cleft palate,
- ossicular defects
- prior surgery,
- unfit patients
- non-compliance
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Outcome of Partial-thickness vs Full-thickness Tragal Cartilage Grafts in Endoscopic Type 1 Tympanoplasty in Adults.
Primary Objective: Compare 6-month graft success rates between 0.5 mm sliced and 1.8 mm full-thickness tragal cartilage grafts.(3) H1: Sliced cartilage yields ≥90% success versus ≤80% for full-thickness.(3) H0: No difference between arms.
Secondary Objectives:
- PTA-ABG closure at 6/12 months.(4)
- Speech discrimination score improvement.(4)
- Operative time.(6)
Read the detailed description
chronic suppurative otitis media with tympanic membrane perforation impacts a large number of adults worldwide, more in rural Upper Egypt due to recurrent infections.(1) These perforations cause ongoing ear discharge, hearing impairment, quality-of-life decline, and increased healthcare costs.(1) Conventional temporalis fascia grafting achieves 80-90% success in small defects but drops below 70% for subtotal/large perforations (>50%tympanic membrane area) or with Eustachian tube issues.(2) Tragal cartilage grafting offers superior durability, with meta-analyses showing 92-98% closure rates versus 82-88% for fascia graft .(3) Full-thickness cartilage (>1.5 mm), however, risks acoustic mass-loading, worsening high-frequency hearing by 8-12 dB at 4 kHz.(4) Partial-thickness slicing (0.4-0.6 mm) maintains strength while enhancing sound transmission, as shown in clinical series.(5) Endoscopic approaches further improve visualization and reduce operative trauma.(6) No randomized trials compare sliced versus full-thickness tragal cartilage in adult endoscopic tympanoplasty.(7,8) This pilot study fills that gap, optimizing technique for local needs before
- Conditions
- Tympanoplasty Surgery
- Being tested
- endoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopeDevice
Also called tympanoplasty
endoscopic type 1 tympano plasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome of partial-thickness vs full-thickness tragal cartilage grafts in endoscopic type 1 tympanoplasty in adults.
Outcome of partial-thickness vs full-thickness tragal cartilage grafts in endoscopic type 1 tympanoplasty in adults.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tympanoplasty SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Gamil Tawfiq, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471191
- Sponsor's protocol ID
- grafts in endoscopy
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Rizer FM. Overlay versus underlay tympanoplasty. Part II: the study. Laryngoscope. 1997 Dec;107(12 Pt 2):26-36. doi: 10.1097/00005537-199712001-00002.
PubMed 9395344
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Partial-thickness vs Full-thickness Tragal Cartilage Grafts in Endoscopic Type 1 Tympanoplasty in Adults.
- ClinicalTrials.gov ID
- NCT07471191
- Acronym / sponsor ID
- grafts in endoscopy
- Conditions
- Tympanoplasty Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Mar 2026 (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.
Primary Objective: Compare 6-month graft success rates between 0.5 mm sliced and 1.8 mm full-thickness tragal cartilage grafts.(3) H1: Sliced cartilage yields ≥90% success versus ≤80% for full-thickness.(3) H0: No difference between arms.
Secondary Objectives:
- PTA-ABG closure at 6/12 months.(4)
- Speech discrimination score improvement.(4)
- Operative time.(6)
Detailed description
chronic suppurative otitis media with tympanic membrane perforation impacts a large number of adults worldwide, more in rural Upper Egypt due to recurrent infections.(1) These perforations cause ongoing ear discharge, hearing impairment, quality-of-life decline, and increased healthcare costs.(1) Conventional temporalis fascia grafting achieves 80-90% success in small defects but drops below 70% for subtotal/large perforations (>50%tympanic membrane area) or with Eustachian tube issues.(2) Tragal cartilage grafting offers superior durability, with meta-analyses showing 92-98% closure rates versus 82-88% for fascia graft .(3) Full-thickness cartilage (>1.5 mm), however, risks acoustic mass-loading, worsening high-frequency hearing by 8-12 dB at 4 kHz.(4) Partial-thickness slicing (0.4-0.6 mm) maintains strength while enhancing sound transmission, as shown in clinical series.(5) Endoscopic approaches further improve visualization and reduce operative trauma.(6) No randomized trials compare sliced versus full-thickness tragal cartilage in adult endoscopic tympanoplasty.(7,8) This pilot study fills that gap, optimizing technique for local needs before
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion (all required): * Age 18-65 years. * safe chronic perforation ≥6 months. * Subtotal (25-75%) or large (>75%) pars tensa defect. * Dry ear ≥3 months (culture-negative). * Intact ossicles, healthy mucosa. * Viable tragal cartilage. * Informed written consent capability. Exclusion criteria : * unsafe otitis, * active discharge, * Eustachian dysfunction e.g cleft palate, * ossicular defects * prior surgery, * unfit patients * non-compliance
Key inclusion criteria (7 listed)
- Age 18-65 years.
- safe chronic perforation ≥6 months.
- Subtotal (25-75%) or large (>75%) pars tensa defect.
- Dry ear ≥3 months (culture-negative).
- Intact ossicles, healthy mucosa.
Key exclusion criteria (7 listed)
- unsafe otitis,
- active discharge,
- Eustachian dysfunction e.g cleft palate,
- ossicular defects
- prior 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 |
|---|---|---|
| endoscopeAlso: tympanoplastyendoscopic type 1 tympano plasty | Device | – |
Primary outcome
Outcome of partial-thickness vs full-thickness tragal cartilage grafts in endoscopic type 1 tympanoplasty in adults.
Time frame: baseline
Outcome of partial-thickness vs full-thickness tragal cartilage grafts in endoscopic type 1 tympanoplasty in adults.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 9395344Rizer FM. Overlay versus underlay tympanoplasty. Part II: the study. Laryngoscope. 1997 Dec;107(12 Pt 2):26-36. doi: 10.1097/00005537-199712001-00002.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Tympanoplasty Surgery, run by Assiut University.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Gamil Tawfiq (01270882995, gamilmonica25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome of partial-thickness vs full-thickness tragal cartilage grafts in endoscopic type 1 tympanoplasty in adults. (time frame: baseline). 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 NCT07471191, which also lists 2 linked publications.
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 13 Mar 2026.