Epistaxis, Anterior Ethmoid ArteryAEANCT05663099
Cauterization of the Anterior Ethmoidal Artery by Transconjunctival Approach
An observational study of Epistaxis, Anterior Ethmoid Artery, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epistaxis, Anterior Ethmoid Artery
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2023to 7 Feb 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patient having un persistent epistaxis after meching
Who may be able to join
- 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.
Who cannot join
- Subject who has expressed opposition to the reuse of his/her data for scientific research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'ORL et de Chirurgie Cervico-Faciale - CHU de Strasbourg - France
Strasbourg, 67091
Léa FATH, MD, 33 3 88 12 64 98, lea.fath@chru-strasbourg.fr
Léa FATH, MD
About this study
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.
Read the 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
- Conditions
- Epistaxis, Anterior Ethmoid Artery
- Keywords
- Epistaxis, Anterior Ethmoid Artery, Arterial hypertension, Hemostasis disorders, Endoscopic sphenopalatine artery, Endonasal endoscopic, Anterior ethmoidectomy
- Medical subject headings
- Epistaxis, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
To retrospectively compare the efficacy of transconjunctival and external cauterization of the anterior ethmoidal artery in patients with refractory epistaxis
The endpoint is the efficacy of the technique with the presence of postoperative epistaxis recurrence
Measured: Files analysed retrospectively from January 01, 2015 to May 01, 2023 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start7 Feb 2023
- Primary completionFeb 2024 (estimated)
- Study completion7 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epistaxis, Anterior Ethmoid ArteryStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663099
- Sponsor's protocol ID
- 8719
- Acronym
- AEA
- Status last verified
- Dec 2022
- First submitted
- 14 Dec 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cauterization of the Anterior Ethmoidal Artery by Transconjunctival Approach
- ClinicalTrials.gov ID
- NCT05663099
- Acronym / sponsor ID
- AEA / 8719
- Conditions
- Epistaxis, Anterior Ethmoid Artery
- Keywords
- Epistaxis, Anterior Ethmoid Artery, Arterial hypertension, Hemostasis disorders, Endoscopic sphenopalatine artery, Endonasal endoscopic, Anterior ethmoidectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- 7 Feb 2024 (estimated)
- First posted
- 23 Dec 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient having un persistent epistaxis after meching
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Subject who has expressed opposition to the reuse of his/her data for scientific research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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.
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 Epistaxis, Anterior Ethmoid Artery, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Léa FATH, MD (33 3 88 12 64 98, lea.fath@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 19 Dec 2023.