Nosebleed (Epistaxis) - Posterior or AnteriorNCT02127554
Long Term Results and Complications After Epistaxis Treatment
An observational study of Nosebleed (Epistaxis) - Posterior or Anterior, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of this study is to find the most agreeable and in the long term most efficient treatment for epistaxis. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Nosebleed (Epistaxis) - Posterior or Anterior
- How many people
- 591 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2014to Dec 2015
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients treated between March 29, 2007 and April 1st, 2008 for epistaxis at the ENT Dept. of the Zurich University Hospital
Who may be able to join
- All patients treated during the study period with known address and who did not decease in the meantime.
Who cannot join
- Insufficiently filled out questionnaires; Obvious lack of ability to remember (as tested by control questions); Known mental disability
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Zurich University Hospital
Zurich, Canton of Zurich, 8091
About this study
Official title: Langzeitresultate Und Komplikationen Nach Einer Epistaxisbehandlung
The aim of this study is to find the most agreeable and in the long term most efficient treatment for epistaxis.
Read the detailed description
In the general population epistaxis occurs quite frequently. Approximately 60% of persons will be affected once in their lifetime, and 6% thereof will seek medical advice. Thereby anterior and posterior epistaxis are discerned. Anterior epistaxis is usually located at the Locus Kisselbachii, while posterior bleeds are found further back in the nose. There, most bleeds will originate from the A. sphenopalatina or the A. ethmoidalis.
Different treatment modalities exist. Anterior epistaxis are usually easier to treat than posterior ones. The aim of this study is to find the most efficient treatment. This involves the assessment of long term results and potential sequelae. Existing data will be complemented with information about recurrences and complications. The question is: Which treatment method leads to the least numbers of recurrences in the long term with the fewest long term sequelae?
Secondly, the most agreeable, least painful treatment method is to be identified. Therefore we will send out questionnaires to patients that were treated between March 29, 2007 and April 1st, 2008 at the Zurich University Hospital.
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Electric coagulation | Patients with anterior epistaxis, treated with electric coagulation | |
| Chemical coagulation | Patients with anterior epistaxis, treated with chemical coagulation | |
| Outpatient tamponade | Patients with posterior epistaxis, treated with tamponade as an outpatient | |
| Inpatient tamponade | Patients with posterior epistaxis, treated with tamponade and kept in the hospital. | |
| Surgery | Patients with posterior epistaxis, treated with surgery as inpatients | |
| Foley balloon catheter | Patients with posterior epistaxis, treated as inpatients with Foley balloon catheter | |
| Combined treatment | Patients with posterior epistaxis, treated as inpatients with a combination of methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients without recurrence
Measured: Up to 8 years post-treatment
Secondary outcomes (1)
Discomfort caused by treatment
Measured: Up to 1 day post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosebleed (Epistaxis) - Posterior or AnteriorStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 591 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Soyka, Dr.med., Principal investigator, Zurich University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127554
- Sponsor's protocol ID
- SM_21_01_2014
- Other IDs
- KEK-ZH-Nr: 2013-0519
- Status last verified
- Dec 2015
- First submitted
- 28 Apr 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Langzeitresultate Und Komplikationen Nach Einer Epistaxisbehandlung
- ClinicalTrials.gov ID
- NCT02127554
- Acronym / sponsor ID
- SM_21_01_2014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Apr 2014 (estimated)
- 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 aim of this study is to find the most agreeable and in the long term most efficient treatment for epistaxis.
Detailed description
In the general population epistaxis occurs quite frequently. Approximately 60% of persons will be affected once in their lifetime, and 6% thereof will seek medical advice. Thereby anterior and posterior epistaxis are discerned. Anterior epistaxis is usually located at the Locus Kisselbachii, while posterior bleeds are found further back in the nose. There, most bleeds will originate from the A. sphenopalatina or the A. ethmoidalis.
Different treatment modalities exist. Anterior epistaxis are usually easier to treat than posterior ones. The aim of this study is to find the most efficient treatment. This involves the assessment of long term results and potential sequelae. Existing data will be complemented with information about recurrences and complications. The question is: Which treatment method leads to the least numbers of recurrences in the long term with the fewest long term sequelae?
Secondly, the most agreeable, least painful treatment method is to be identified. Therefore we will send out questionnaires to patients that were treated between March 29, 2007 and April 1st, 2008 at the Zurich University Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Electric coagulation | – | –Patients with anterior epistaxis, treated with electric coagulation |
| Chemical coagulation | – | –Patients with anterior epistaxis, treated with chemical coagulation |
| Outpatient tamponade | – | –Patients with posterior epistaxis, treated with tamponade as an outpatient |
| Inpatient tamponade | – | –Patients with posterior epistaxis, treated with tamponade and kept in the hospital. |
| Surgery | – | –Patients with posterior epistaxis, treated with surgery as inpatients |
| Foley balloon catheter | – | –Patients with posterior epistaxis, treated as inpatients with Foley balloon catheter |
| Combined treatment | – | –Patients with posterior epistaxis, treated as inpatients with a combination of methods |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated between March 29, 2007 and April 1st, 2008 for epistaxis at the ENT Dept. of the Zurich University Hospital
Key inclusion criteria (1 listed)
- All patients treated during the study period with known address and who did not decease in the meantime.
Key exclusion criteria (1 listed)
- Insufficiently filled out questionnaires; Obvious lack of ability to remember (as tested by control questions); Known mental disability
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
Number of patients without recurrence
Time frame: Up to 8 years post-treatment
1 secondary outcome
Discomfort caused by treatment
Time frame: Up to 1 day post-treatment
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 2 Dec 2015.
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.
Michael Soyka, Dr.med. principal investigator
Zurich University Hospital
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 Nosebleed (Epistaxis) - Posterior or Anterior, run by University of Zurich at 1 site in Switzerland.
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 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: finished, as of the sponsor's last update on 2 Dec 2015. 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 Switzerland. 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?
Number of patients without recurrence (time frame: Up to 8 years post-treatment). 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 2 Dec 2015.