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RecruitingNCT05281952EPICOSTUpdated Aug 29, 2023

Medico-economic Evaluation of Management Strategies for Severe Epistaxis

An interventional study of endoscopic ligation and Supra-selective embolization in Epistaxis, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-29.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started May 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Epistaxis

Browse trials for

Keywords

  • Severe epistaxis
  • endoscopic ligation
  • Supra-selective embolization
03

In context

Epistaxis

96 studies on the registry are indexed under Epistaxis; 22 are open to participants now.

This study's planned enrollment of 180 is above the median of 64 across 81 interventional studies indexed under Epistaxis.

Browse Epistaxis studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 to general anesthesia: severe and/or decompensated cardiac/hepatic/renal insufficiency, 4
  • Severe hemostasis disorders that cannot benefit from correction.
  • History of transient and/or definitive stroke of the ischemic type
  • Atheromatous overload
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    endoscopic ligation

    Procedure: endoscopic ligation

  • Active comparator
    Supra-selective embolization

    Procedure: Supra-selective embolization

Interventions

  • Procedureendoscopic ligation

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

  • ProcedureSupra-selective embolization

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

06

What researchers measure

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

  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

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

    Time frame: Month 18

  11. the description of the costs of care

    only for non-randomized patients

    Time frame: Month 18

  12. financial benefit (1 year)

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

    Time frame: Month 12

  13. 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

    Time frame: Year 5

07

Study locations

1 of 1 sites recruiting
  • University Hospital
    Toulouse, France
    Recruiting
    • Guillaume DE BONNECAZE, MD · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2023 (actual). Primary completion is estimated for Dec 2026, 43 months after the start.

Of 24 interventional studies with no phase under Epistaxis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 25. This study's planned 43 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2022
First posted
Mar 16, 2022
StartActual
May 1, 2023
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Aug 29, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05281952
Responsible party
Sponsor
First posted
Mar 16, 2022
Start date
May 1, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 29, 2023

Study contacts

Guillaume DE BONNECAZE, MD
Contact
debonnecaze.g@chu-toulouse.fr
0567771641 ext. +33
Guillaume DE BONNECAZE, MD
principal investigator · Toulouse University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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