Medico-economic Evaluation of Management Strategies for Severe Epistaxis

Study Overview
=================
Brief Summary
-----------------
Current recommendations consider surgical ligation and supra-selective embolization as equivalent in terms of efficacy and there is no clear consensus to choose between one and the other technique. In the absence of medico-economic studies, these recommendations could not be based on any differences in efficiency between the two techniques. The management of patients with severe non-traumatic epistaxis remains controversial and varies according to the hospital and/or university centers. In practice, the use of one or the other technique depends on the habits of each reference center.

Detailed Description
-----------------
The hypothesis is that early ligation of the sphenopalatine arteries would reduce the costs of care for the community while improving the quality of life of patients compared to supra-elective embolization. This medico-economic superiority could go through: reduction in the number of recurrences reduction in the length of hospital stays. reduction in the cost of postoperative care. reduction of iatrogenic complications improvement of functional suites upon return home. Tertiary prevention of dependency, particularly among the elderly

Official Title
-----------------
Medico-economic Evaluation of Management Strategies for Severe Epistaxis

Conditions
-----------------
Epistaxis

Intervention / Treatment
-----------------
* Procedure: endoscopic ligation
* Procedure: Supra-selective embolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with severe epistaxis who failed treatment with double tamponade for more than 48 hours. Patient over 18 years old Affiliated patient or beneficiary of a social security scheme. Patient accepting the principle of randomization Free, informed and written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria: Patient with epistaxis secondary to facial and/or surgical trauma. Patient with epistaxis related to a malignant tumor cause Patient with a history of ligation or embolization Patient under legal protection and/or curatorship and/or guardianship. Impossibility of giving the person informed information and ensuring the subject's compliance due to impaired physical and/or psychological health. Patient participating in another research including an exclusion period still in progress Pregnant or breastfeeding patient For non randomized patient Patient with a contraindication to general anesthesia: severe and/or decompensated cardiac/hepatic/renal insufficiency, ASA score 4 Severe hemostasis disorders that cannot benefit from correction. History of transient and/or definitive stroke of the ischemic type Atheromatous overload

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomization in two groups: endoscopic ligation or supra-selective embolization and real-life study for a third group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endoscopic ligation<br> | Procedure: endoscopic ligation<br>* the surgical ligation of one or both sphenopalatine arteries by endoscopic way.<br>|
| Active Comparator: Supra-selective embolization<br> | Procedure: Supra-selective embolization<br>* occlusion of the terminal branches of the nasal external carotid artery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incremental cost-utility ratio | the cost-utility ratio integrating direct medical and non-medical costs | Month 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of recurrences |  | Month 18 | 
| time to first recurrence |  | Month 18 | 
| the number of complications |  | Month 18 | 
| nature of complications |  | Month 18 | 
| quality of life with EQ-5D-5L |  | Month 18 | 
| quality of life with SNOT 22 |  | Month 18 | 
| the number of hospitalizations |  | Month 18 | 
| duration of hospitalizations |  | Month 18 | 
| the addiction with KATZ scale |  | Month 18 | 
| incremental cost-effectiveness ratio | the incremental cost-effectiveness ratio (cost/number of recurrences avoided) from the perspective of the community | Month 18 | 
| the description of the costs of care | only for non-randomized patients | Month 18 | 
| financial benefit (1 year) | the annual financial benefit of routine implementation of arterial ligation in the treatment of severe epistaxis, from a community perspective | Month 12 | 
| financial benefit (5 year) | the 5-year financial benefit of routine implementation of arterial ligation in the treatment of severe epistaxis, from a community perspective | Year 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe epistaxis, endoscopic ligation, Supra-selective embolization