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NCT Number: NCT05281952

Medico-economic Evaluation of Management Strategies for Severe Epistaxis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Toulouse, France

Location status: Recruiting

Location contact

Guillaume DE BONNECAZE, MD

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic ligation

Procedure

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

Supra-selective embolization

Procedure

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

Primary outcomes

  1. incremental cost-utility ratio

    Time frame: Month 18

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

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

  5. quality of life with EQ-5D-5L

    Time frame: Month 18

  6. quality of life with SNOT 22

    Time frame: Month 18

  7. the number of hospitalizations

    Time frame: Month 18

  8. duration of hospitalizations

    Time frame: Month 18

  9. the addiction with KATZ scale

    Time frame: Month 18

  10. incremental cost-effectiveness ratio

    Time frame: Month 18

    the incremental cost-effectiveness ratio (cost/number of recurrences avoided) from the perspective of the community

  11. the description of the costs of care

    Time frame: Month 18

    only for non-randomized patients

  12. financial benefit (1 year)

    Time frame: Month 12

    the annual financial benefit of routine implementation of arterial ligation in the treatment of severe epistaxis, from a community perspective

  13. financial benefit (5 year)

    Time frame: Year 5

    the 5-year financial benefit of routine implementation of arterial ligation in the treatment of severe epistaxis, from a community perspective

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume DE BONNECAZE, MD

CONTACT

[email protected]

0567771641 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: EPICOST

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2022
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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