Epistaxis
Conditions
Keywords
Severe epistaxis, endoscopic ligation, Supra-selective embolization
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
Interventions
PROCEDUREendoscopic ligation
the surgical ligation of one or both sphenopalatine arteries by endoscopic way.
PROCEDURESupra-selective embolization
occlusion of the terminal branches of the nasal external carotid artery.
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
randomization in two groups: endoscopic ligation or supra-selective embolization and real-life study for a third group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incremental cost-utility ratio | Month 18 | the cost-utility ratio integrating direct medical and non-medical costs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| number of recurrences | Month 18 | — |
| the addiction with KATZ scale | Month 18 | — |
| incremental cost-effectiveness ratio | Month 18 | the incremental cost-effectiveness ratio (cost/number of recurrences avoided) from the perspective of the community |
| the description of the costs of care | Month 18 | only for non-randomized patients |
| financial benefit (1 year) | Month 12 | the annual financial benefit of routine implementation of arterial ligation in the treatment of severe epistaxis, from a community perspective |
| financial benefit (5 year) | Year 5 | the 5-year financial benefit of routine implementation of arterial ligation in the treatment of severe epistaxis, from a community perspective |
| duration of hospitalizations | Month 18 | — |
Countries
France
Contacts
Primary ContactGuillaume DE BONNECAZE, MD
Outcome results
None listed