- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05532462
Trans-nasal Complete Nasolabial Cyst Excision
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Sohag, Egypt, 82524
- Mohammed Elrabie Ahmed
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
•Nasolabial cyst
Exclusion Criteria:
- Recurrent cases
- Previous operated
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms and clinical sign
Time Frame: 2 years
|
The presenting symptoms which made the patient sought medical advice
|
2 years
|
Preoperative Computer tomography or soft tissue ultrasound
Time Frame: 2 years
|
Radiological description of the lesion
|
2 years
|
lining epithelium and inflammatory cell in wall of histopathology
Time Frame: 2 years
|
histopathological criteria of the epithelium and cyst wall
|
2 years
|
complications and outcome
Time Frame: 2 years
|
postoperative complication or recurrence
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SH_1180
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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