Tympanic Membrane PerforationNCT03922295
Endoscopic Tympanoplasty: Single Versus Double Flap Technique
A study testing Endoscopic tympanoplasty in people with Tympanic Membrane Perforation, run by Mansoura University at 1 site in Egypt.
Trial summary
Aim of this study is to compare results of double and single flap techniques for tympanoplasty in chronic suppurative otitis media patients. Inclusion criteria include total or subtotal tympanic membrane perforations with limited anterior remnant and should be dry for at least 3 months. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Endoscopic tympanoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Aug 2017to 20 Feb 2019
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with chronic suppurative otitis media with total or subtotal tympanic membrane perforation with limited anterior remnant.
- dry perforation for at least 3 months.
Who cannot join
- Recurrent perforation after previous myringoplasty.
- Ossicular disruption or fixation.
- immune-compromised patients including uncontrolled diabetics, chronic liver and kidney diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
Al Mansurah, ElDakahlia, 35516
About this study
Aim of this study is to compare results of double and single flap techniques for tympanoplasty in chronic suppurative otitis media patients. Inclusion criteria include total or subtotal tympanic membrane perforations with limited anterior remnant and should be dry for at least 3 months. Patients with persistent discharge, cholesteatoma, ossicular affection or those with recurrent perforations after previous myringoplasty were excluded. Also, patients with uncontrolled diabetes, chronic liver and kidney diseases and immuno-compromised patients are not included in this study. Patients are divided into two groups, endoscopic double flap group and endoscopic single flap group. Healing and hearing outcomes were evaluated 3 months postoperative. Also, post-operative pain scores and complications were assessed.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Endoscopic tympanoplasty
- 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 tympanoplastyProcedure or surgery
In the double flap group, graft is placed via elevation of both posterior and anterior flaps.
In the single flap group, graft is placed via elevation of posterior flap only
| Study group | Role | What they receive |
|---|---|---|
| endoscopic double flap group | Active comparator | Not described Receives: Procedure: Endoscopic tympanoplasty |
| endoscopic single flap group | Active comparator | Not described Receives: Procedure: Endoscopic tympanoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing or graft take rate
closure of tympanic membrane perforation
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start24 Aug 2017
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha A.Elkholy, Mansoura University
- Investigators
- Noha A Elkholy, Principal investigator, ORL-HNS department, Faculty of Medicine, Mansoura UniversityMohammed A Salem, Study director, ORL-HNS department, Faculty of Medicine, Mansoura UniversityAbdelwahab M Rakha, Study chair, ORL-HNS department, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922295
- Sponsor's protocol ID
- 1ORL
- Status last verified
- Sep 2019
- First submitted
- 16 Apr 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El-Kholy NA, Salem MA, Rakha AM. Endoscopic single versus double flap tympanoplasty: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2021 May;278(5):1395-1401. doi: 10.1007/s00405-020-06212-3. Epub 2020 Jul 20.
PubMed 32691232
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Tympanoplasty: Single Versus Double Flap Technique
- ClinicalTrials.gov ID
- NCT03922295
- Acronym / sponsor ID
- 1ORL
- Conditions
- Tympanic Membrane Perforation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 19 Apr 2019 (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.
Aim of this study is to compare results of double and single flap techniques for tympanoplasty in chronic suppurative otitis media patients. Inclusion criteria include total or subtotal tympanic membrane perforations with limited anterior remnant and should be dry for at least 3 months. Patients with persistent discharge, cholesteatoma, ossicular affection or those with recurrent perforations after previous myringoplasty were excluded. Also, patients with uncontrolled diabetes, chronic liver and kidney diseases and immuno-compromised patients are not included in this study. Patients are divided into two groups, endoscopic double flap group and endoscopic single flap group. Healing and hearing outcomes were evaluated 3 months postoperative. Also, post-operative pain scores and complications were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopic double flap group | Active comparator | Procedure: Endoscopic tympanoplasty |
| endoscopic single flap group | Active comparator | Procedure: Endoscopic tympanoplasty |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with chronic suppurative otitis media with total or subtotal tympanic membrane perforation with limited anterior remnant.
- dry perforation for at least 3 months.
Key exclusion criteria (3 listed)
- Recurrent perforation after previous myringoplasty.
- Ossicular disruption or fixation.
- immune-compromised patients including uncontrolled diabetics, chronic liver and kidney diseases.
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 tympanoplastyIn the double flap group, graft is placed via elevation of both posterior and anterior flaps. In the single flap group, graft is placed via elevation of posterior flap only | Procedure or surgery | endoscopic double flap group, endoscopic single flap group |
Primary outcome
Healing or graft take rate
Time frame: 3 months after surgery
closure of tympanic membrane perforation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Derived from this study: PubMed 32691232El-Kholy NA, Salem MA, Rakha AM. Endoscopic single versus double flap tympanoplasty: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2021 May;278(5):1395-1401. doi: 10.1007/s00405-020-06212-3. Epub 2020 Jul 20.
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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. This study is not recruiting at the moment.
Noha A Elkholy principal investigator
ORL-HNS department, Faculty of Medicine, Mansoura University
Mohammed A Salem study director
ORL-HNS department, Faculty of Medicine, Mansoura University
Abdelwahab M Rakha study chair
ORL-HNS department, Faculty of Medicine, Mansoura University
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 tympanoplasty in people with Tympanic Membrane Perforation, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 10 Sep 2019. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing or graft take rate (time frame: 3 months after surgery). 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 NCT03922295, 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 10 Sep 2019.