Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02824-35 | Other Identifier | ID-RCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoscopic ligation | Experimental |
| |
| Supra-selective embolization | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic ligation | Procedure | the surgical ligation of one or both sphenopalatine arteries by endoscopic way. |
|
| Measure | Description | Time Frame |
|---|---|---|
| incremental cost-utility ratio | the cost-utility ratio integrating direct medical and non-medical costs | Month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| number of recurrences | Month 18 | |
| time to first recurrence | Month 18 | |
| the number of complications |
Not provided
Inclusion Criteria:
Exclusion Criteria:
For non randomized patient
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume DE BONNECAZE, MD | Contact | 0567771641 | +33 | debonnecaze.g@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Guillaume DE BONNECAZE, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Recruiting | Toulouse | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004844 | Epistaxis |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006470 | Hemorrhage |
Not provided
Not provided
randomization in two groups: endoscopic ligation or supra-selective embolization and real-life study for a third group
Not provided
Not provided
Not provided
Not provided
| Supra-selective embolization | Procedure | occlusion of the terminal branches of the nasal external carotid artery. |
|
| 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 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |