- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05663099
Cauterization of the Anterior Ethmoidal Artery by Transconjunctival Approach (AEA)
December 13, 2023 updated by: University Hospital, Strasbourg, France
The incidence of epistaxis varies from 7 to 14% in the general population and represents 30 per 100,000 emergency room admissions in adults.
Most nasal bleeding is self-limiting without the need for specific medical treatment.
Cauterization under local anesthesia and control of medical comorbidities (arterial hypertension and hemostasis disorders) are effective in most cases.
In case of failure of cauterization or in case of more posterior epistaxis, an antero-posterior packing can be put in place for 48 hours.
In case of failure or recurrence of packing removal, endoscopic sphenopalatine artery (SPA) ligation or embolization is proposed.
In case of persistent epistaxis despite hemostasis of the PSA, ligation of the anterior ethmoidal artery (AEA) is recommended.
This artery cannot be embolized because of the risk to the ophthalmic artery.
The ligation of the AEA is most often performed via the external paracanthal approach.
It can also be performed by endonasal endoscopic approach but involves the performance of an anterior ethmoidectomy, a long surgery with a significant risk of complications.
Its identification by the endonasal route is complicated in the event of abundant bleeding.
Moreover, its endoscopic cauterization is difficult if the artery is not procidente.
The transconjunctival approach avoids a visible scar and the complications of an ethmoidectomy.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The objective of the study was to compare the efficacy of transconjunctival and external cauterization of the anterior ethmoidal artery in patients with refractory epistaxis
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Léa FATH, MD
- Phone Number: 33 3 88 12 64 98
- Email: lea.fath@chru-strasbourg.fr
Study Locations
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Strasbourg, France, 67091
- Recruiting
- Service d'ORL et de Chirurgie Cervico-Faciale - CHU de Strasbourg - France
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Sub-Investigator:
- Idir DJENNAOUI, MD
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Contact:
- Léa FATH, MD
- Phone Number: 33 3 88 12 64 98
- Email: lea.fath@chru-strasbourg.fr
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Principal Investigator:
- Léa FATH, MD
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Principal Investigator:
- Alexandra LEON, MD
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Sub-Investigator:
- Christian DEBRY, MD, PhD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Adult patient having un persistent epistaxis after meching
Description
Inclusion criteria:
- Male or female (age ≥18 years)
- Persistent epistaxis after meching
- Having required transconjunctival anterior ethmoidal artery cauterization surgery
- Subject operated at the University Hospitals of Strasbourg between 01/01/2015 and 01/05/2023
- Subject not objecting to the reuse of his/her data for scientific research purposes.
Exclusion Criteria:
- Subject who has expressed opposition to the reuse of his/her data for scientific research purposes.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To retrospectively compare the efficacy of transconjunctival and external cauterization of the anterior ethmoidal artery in patients with refractory epistaxis
Time Frame: Files analysed retrospectively from January 01, 2015 to May 01, 2023 will be examined
|
The endpoint is the efficacy of the technique with the presence of postoperative epistaxis recurrence
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Files analysed retrospectively from January 01, 2015 to May 01, 2023 will be examined
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2023
Primary Completion (Estimated)
February 1, 2024
Study Completion (Estimated)
February 7, 2024
Study Registration Dates
First Submitted
December 14, 2022
First Submitted That Met QC Criteria
December 21, 2022
First Posted (Actual)
December 23, 2022
Study Record Updates
Last Update Posted (Actual)
December 19, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8719
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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