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Medico-economic Evaluation of Management Strategies for Severe Epistaxis

ConditionEpistaxis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • endoscopic ligation

    Procedure/Surgery

    the surgical ligation of one or both sphenopalatine arteries by endoscopic way.

  • Supra-selective embolization

    Procedure/Surgery

    occlusion of the terminal branches of the nasal external carotid artery.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: endoscopic ligationExperimental treatment 1 intervention
Group B: Supra-selective embolizationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

incremental cost-utility ratio

the cost-utility ratio integrating direct medical and non-medical costs

Time frame
Month 18

Secondary outcomes

1

number of recurrences

Time frame
Month 18
2

time to first recurrence

Time frame
Month 18
3

the number of complications

Time frame
Month 18
4

nature of complications

Time frame
Month 18

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov
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