Nasolabial CystNCT05532462
Trans-nasal Complete Nasolabial Cyst Excision
An observational study of Nasolabial Cyst, run by Sohag University at 1 site in Egypt.
Trial summary
Background: Nasolabial cysts are rare benign epithelial nonodontogenic soft tissue cysts arising in the nasal alar region. Sublabial excision or transnasal endoscopic marsupialization is the standard treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasolabial Cyst
- What is being tested?
- Trans-nasal complete nasalabial cyst excision
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2022to 5 Jul 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: In upper Egypt In sohag universiy hospital terriary center
Who may be able to join
- •Nasolabial cyst
Who cannot join
- Recurrent cases
- Previous operated
Trial locations and contacts
1 site in 1 country.
About this study
Background: Nasolabial cysts are rare benign epithelial nonodontogenic soft tissue cysts arising in the nasal alar region. Sublabial excision or transnasal endoscopic marsupialization is the standard treatment.
Patients and methods: Between 2019 and 2022, a descriptive retrospective study, including 20 patients who presented with Nasolabial cysts, was conducted.
Read the detailed description
A retrospective study of patients who were presented in the period from 2019 to 2022, with nasolabial cysts. Patients' files were checked for demographic data, clinical presentation, preoperative radiological investigations, histopathology, surgical approach, complications, and outcome.
Technique:
The surgery is carried out mainly using x5 magnification loupe and 0° degree sinoscope. Submucosal infiltration (lidocaine 2% and 1:100,000 adrenaline). An incision was made at the mucosal covering of the cyst wall and nasal floor in a transverse and anteroposterior direction. The mucosal flap is elevated and separated from the cyst wall and reflected toward the septum side. During dissection, cyst content is usually drained. The whole cyst wall was carefully dissected with sharp and blunt dissection from the mucous membrane, and laterally from the premaxillary area. Finally, endoscopic examination to check the operative bed and refashioning mucosal flap coverage. If mucosal flap is lacerated, then excised and operative bed left for healing by creeping from surrounding edges. Endoscopic trans-nasal complete excision has a shorter operative time, minimal intraoperative bleeding, and no postoperative pain or edema reported.
- Conditions
- Nasolabial Cyst
- Being tested
- Trans-nasal complete nasalabial cyst excision
- Keywords
- Nasoalveolar - Nasolabial - Klestadt's - Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-nasal complete nasalabial cyst excisionProcedure or surgery
Also called sublabial approach
The surgery is carried out mainly using x5 magnification loupe and 0° degree sinoscope. Submucosal infiltration (lidocaine 2% and 1:100,000 adrenaline). An incision was made at the mucosal covering of the cyst wall and nasal floor in a transverse and anteroposterior direction. The mucosal flap is elevated and separated from the cyst wall and reflected toward the septum side. During dissection, cyst content is usually drained. The whole cyst wall was carefully dissected with sharp and blunt dissection from the mucous membrane, and laterally from the premaxillary area. Finally, endoscopic examination to check the operative bed and refashioning mucosal flap coverage. If mucosal flap is lacerated, then excised and operative bed left for healing by creeping from surrounding edges. Endoscopic trans-nasal complete excision has a shorter operative time, minimal intraoperative bleeding, and no postoperative pain or edema reported.
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms and clinical sign
The presenting symptoms which made the patient sought medical advice
Measured: 2 years
Preoperative Computer tomography or soft tissue ultrasound
Radiological description of the lesion
Measured: 2 years
lining epithelium and inflammatory cell in wall of histopathology
histopathological criteria of the epithelium and cyst wall
Measured: 2 years
complications and outcome
postoperative complication or recurrence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start25 Mar 2022
- Primary completion22 May 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial CystStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ibrahim Yousef, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532462
- Sponsor's protocol ID
- SH_1180
- Status last verified
- Sep 2022
- First submitted
- 24 Aug 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A retrospective study of patients who were presented in the period from 2019 to 2022, with nasolabial cysts
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-nasal Complete Nasolabial Cyst Excision
- ClinicalTrials.gov ID
- NCT05532462
- Acronym / sponsor ID
- SH_1180
- Conditions
- Nasolabial Cyst
- Keywords
- Nasoalveolar - Nasolabial - Klestadt's - Cyst
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 22 May 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 8 Sep 2022 (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.
Background: Nasolabial cysts are rare benign epithelial nonodontogenic soft tissue cysts arising in the nasal alar region. Sublabial excision or transnasal endoscopic marsupialization is the standard treatment.
Patients and methods: Between 2019 and 2022, a descriptive retrospective study, including 20 patients who presented with Nasolabial cysts, was conducted.
Detailed description
A retrospective study of patients who were presented in the period from 2019 to 2022, with nasolabial cysts. Patients' files were checked for demographic data, clinical presentation, preoperative radiological investigations, histopathology, surgical approach, complications, and outcome.
Technique:
The surgery is carried out mainly using x5 magnification loupe and 0° degree sinoscope. Submucosal infiltration (lidocaine 2% and 1:100,000 adrenaline). An incision was made at the mucosal covering of the cyst wall and nasal floor in a transverse and anteroposterior direction. The mucosal flap is elevated and separated from the cyst wall and reflected toward the septum side. During dissection, cyst content is usually drained. The whole cyst wall was carefully dissected with sharp and blunt dissection from the mucous membrane, and laterally from the premaxillary area. Finally, endoscopic examination to check the operative bed and refashioning mucosal flap coverage. If mucosal flap is lacerated, then excised and operative bed left for healing by creeping from surrounding edges. Endoscopic trans-nasal complete excision has a shorter operative time, minimal intraoperative bleeding, and no postoperative pain or edema reported.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In upper Egypt In sohag universiy hospital terriary center
Key inclusion criteria (1 listed)
- •Nasolabial cyst
Key exclusion criteria (2 listed)
- Recurrent cases
- Previous operated
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 |
|---|---|---|
| Trans-nasal complete nasalabial cyst excisionAlso: sublabial approachThe surgery is carried out mainly using x5 magnification loupe and 0° degree sinoscope. Submucosal infiltration (lidocaine 2% and 1:100,000 adrenaline). An incision was made at the mucosal covering of the cyst wall and nasal floor in a transverse and anteroposterior direction. The mucosal flap is elevated and separated from the cyst wall and reflected toward the septum side. During dissection, cyst content is usually drained. The whole cyst wall was carefully dissected with sharp and blunt dissection from the mucous membrane, and laterally from the premaxillary area. Finally, endoscopic examination to check the operative bed and refashioning mucosal flap coverage. If mucosal flap is lacerated, then excised and operative bed left for healing by creeping from surrounding edges. Endoscopic trans-nasal complete excision has a shorter operative time, minimal intraoperative bleeding, and no postoperative pain or edema reported. | Procedure or surgery | – |
Primary outcome
Symptoms and clinical sign
Time frame: 2 years
The presenting symptoms which made the patient sought medical advice
Preoperative Computer tomography or soft tissue ultrasound
Time frame: 2 years
Radiological description of the lesion
lining epithelium and inflammatory cell in wall of histopathology
Time frame: 2 years
histopathological criteria of the epithelium and cyst wall
complications and outcome
Time frame: 2 years
postoperative complication or recurrence
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 8 Sep 2022.
- Individual participant dataSharing planned: No. A retrospective study of patients who were presented in the period from 2019 to 2022, with nasolabial cysts
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasolabial Cyst, run by Sohag 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 1 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 8 Sep 2022. 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?
Symptoms and clinical sign (time frame: 2 years). The study lists 4 primary outcomes in all. 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 8 Sep 2022.