Clinical trial NCT05281952: Medico-economic Evaluation of Management Strategies for Severe Epistaxis
Official title: Medico-economic Evaluation of Management Strategies for Severe Epistaxis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epistaxis
Keywords: Severe epistaxis
endoscopic ligation
Supra-selective embolization
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomization in two groups: endoscopic ligation or supra-selective embolization and real-life study for a third group
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Primary outcomes:
measure: incremental cost-utility ratio
timeFrame: Month 18
Secondary outcomes:
measure: number of recurrences
timeFrame: Month 18
measure: time to first recurrence
timeFrame: Month 18
measure: the number of complications
timeFrame: Month 18
measure: nature of complications
timeFrame: Month 18
measure: quality of life with EQ-5D-5L
timeFrame: Month 18
measure: quality of life with SNOT 22
timeFrame: Month 18
measure: the number of hospitalizations
timeFrame: Month 18
measure: duration of hospitalizations
timeFrame: Month 18
measure: the addiction with KATZ scale
timeFrame: Month 18
measure: incremental cost-effectiveness ratio
timeFrame: Month 18
measure: the description of the costs of care
timeFrame: Month 18
measure: financial benefit (1 year)
timeFrame: Month 12
measure: financial benefit (5 year)
timeFrame: Year 5
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Guillaume DE BONNECAZE, MD
role: PRINCIPAL_INVESTIGATOR
References: