Superficial Cyst or Mass and Sinus on and Around the EarNCT04497337
The Superficial Lesions in the Peri-auricular Region
A study testing Complete excision to superficial lesions around the ear in people with Superficial Cyst or Mass and Sinus on and Around the Ear, run by Mohammed Elrabie Ahmed at 1 site in Egypt.
Trial summary
Superficial lesions on and around the ear are uncommon with many differential diagnoses and different characteristic histopathologic features. The purpose of this study was to describe a series of peri-auricular superficial lesions and characterize the distinctive types of these lesions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Superficial Cyst or Mass and Sinus on and Around the Ear
- What is being tested?
- Complete excision to superficial lesions around the ear
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2019to 20 Jun 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) operated during the period extending between 2017 and 2019
- Available full demographic, clinical and histopathological data
Who cannot join
- deep lesions involving parotid or parapharyngeal space
- Missed demographic, clinical and histopathological data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Superficial Lesions in the Peri-auricular Region; Retrospective Study
Superficial lesions on and around the ear are uncommon with many differential diagnoses and different characteristic histopathologic features. The purpose of this study was to describe a series of peri-auricular superficial lesions and characterize the distinctive types of these lesions.
Read the detailed description
Data included in this descriptive retrospective study were collected from records of 70 patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) during the period extending between 2017 and 2019, who were primarily diagnosed and operated. Data were retrieved, reviewed, and analyzed. The primary analysis outcome measures were patient history (age, gender, complaint, medical advice clinic, and associated medical diseases), lesions examination (site, laterality, clinical presentation, and the number of lesions). Also, the needed investigations for diagnosis, type of intervention, postoperative patient satisfaction were evaluated. Evaluation of the patients' follow up was done.
- Being tested
- Complete excision to superficial lesions around the ear
- Medical subject headings
- Arachnodactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete excision to superficial lesions around the earProcedure or surgery
Complete excision of these lesions and histopathology
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical and Histopathlogical types of superficial lesion around the ear
Measured: Cases operated between in the previous 3 years from 2017 and 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start12 Dec 2019
- Primary completion16 May 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Cyst or Mass and Sinus on and Around the EarStudies 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
- Data included in this descriptive retrospective study were collected from records of 70 patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) during the period extending between 2017 and 2019, who were primarily diagnosed and operated
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed Elrabie Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Elrabie Ahmed, Sohag University
- Investigators
- Sohag University hospital, Study director, Nasr City, Eastern Avenue, University Street, Sohag, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497337
- Sponsor's protocol ID
- 18630159
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Superficial Lesions in the Peri-auricular Region; Retrospective Study
- ClinicalTrials.gov ID
- NCT04497337
- Acronym / sponsor ID
- 18630159
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mohammed Elrabie AhmedUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 16 May 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 4 Aug 2020 (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.
Superficial lesions on and around the ear are uncommon with many differential diagnoses and different characteristic histopathologic features. The purpose of this study was to describe a series of peri-auricular superficial lesions and characterize the distinctive types of these lesions.
Detailed description
Data included in this descriptive retrospective study were collected from records of 70 patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) during the period extending between 2017 and 2019, who were primarily diagnosed and operated. Data were retrieved, reviewed, and analyzed. The primary analysis outcome measures were patient history (age, gender, complaint, medical advice clinic, and associated medical diseases), lesions examination (site, laterality, clinical presentation, and the number of lesions). Also, the needed investigations for diagnosis, type of intervention, postoperative patient satisfaction were evaluated. Evaluation of the patients' follow up was done.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Data included in this descriptive retrospective study were collected from records of 70 patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) during the period extending between 2017 and 2019, who were primarily diagnosed and operated
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) operated during the period extending between 2017 and 2019
- Available full demographic, clinical and histopathological data
Key exclusion criteria (2 listed)
- deep lesions involving parotid or parapharyngeal space
- Missed demographic, clinical and histopathological data
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 |
|---|---|---|
| Complete excision to superficial lesions around the earComplete excision of these lesions and histopathology | Procedure or surgery | – |
Primary outcome
clinical and Histopathlogical types of superficial lesion around the ear
Time frame: Cases operated between in the previous 3 years from 2017 and 2019
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 4 Aug 2020.
- Individual participant dataSharing planned: Undecided
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.
Sohag University hospital study director
Nasr City, Eastern Avenue, University Street, Sohag, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete excision to superficial lesions around the ear in people with Superficial Cyst or Mass and Sinus on and Around the Ear, run by Mohammed Elrabie Ahmed 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 2 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 4 Aug 2020. 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?
clinical and Histopathlogical types of superficial lesion around the ear (time frame: Cases operated between in the previous 3 years from 2017 and 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2020.