Medico-economic Evaluation of Management Strategies for Severe Epistaxis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: endoscopic ligation, Supra-selective embolization.
- Who it may be relevant to
- Registry conditions: Epistaxis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure endoscopic ligation
the surgical ligation of one or both sphenopalatine arteries by endoscopic way. - Procedure Supra-selective embolization
occlusion of the terminal branches of the nasal external carotid artery.
Primary outcome measures
- incremental cost-utility ratio [Time frame: Month 18]
Secondary outcome measures (12)
- number of recurrences [Time frame: Month 18]
- time to first recurrence [Time frame: Month 18]
- the number of complications [Time frame: Month 18]
- nature of complications [Time frame: Month 18]
- quality of life with EQ-5D-5L [Time frame: Month 18]
- quality of life with SNOT 22 [Time frame: Month 18]
- the number of hospitalizations [Time frame: Month 18]
- duration of hospitalizations [Time frame: Month 18]
- the addiction with KATZ scale [Time frame: Month 18]
- incremental cost-effectiveness ratio [Time frame: Month 18]
- the description of the costs of care [Time frame: Month 18]
- financial benefit (1 year) [Time frame: Month 12]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 1 center
- University Hospital — Toulouse
Identifiers
NCT: NCT05281952 · RC31/19-0550 · 2020-A02824-35