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Medico-economic Evaluation of Management Strategies for Severe Epistaxis (EPICOST)

Primary Purpose

Epistaxis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
endoscopic ligation
Supra-selective embolization
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Epistaxis focused on measuring Severe epistaxis, endoscopic ligation, Supra-selective embolization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

endoscopic ligation

Supra-selective embolization

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

number of recurrences
time to first recurrence
the number of complications
nature of complications
quality of life with EQ-5D-5L
quality of life with SNOT 22
the number of hospitalizations
duration of hospitalizations
the addiction with KATZ scale
incremental cost-effectiveness ratio
the incremental cost-effectiveness ratio (cost/number of recurrences avoided) from the perspective of the community
the description of the costs of care
only for non-randomized patients
financial benefit (1 year)
the annual financial benefit of routine implementation of arterial ligation in the treatment of severe epistaxis, from a community perspective
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

Full Information

First Posted
March 7, 2022
Last Updated
August 25, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05281952
Brief Title
Medico-economic Evaluation of Management Strategies for Severe Epistaxis
Acronym
EPICOST
Official Title
Medico-economic Evaluation of Management Strategies for Severe Epistaxis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis
Keywords
Severe epistaxis, endoscopic ligation, Supra-selective embolization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomization in two groups: endoscopic ligation or supra-selective embolization and real-life study for a third group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endoscopic ligation
Arm Type
Experimental
Arm Title
Supra-selective embolization
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
endoscopic ligation
Intervention Description
the surgical ligation of one or both sphenopalatine arteries by endoscopic way.
Intervention Type
Procedure
Intervention Name(s)
Supra-selective embolization
Intervention Description
occlusion of the terminal branches of the nasal external carotid artery.
Primary Outcome Measure Information:
Title
incremental cost-utility ratio
Description
the cost-utility ratio integrating direct medical and non-medical costs
Time Frame
Month 18
Secondary Outcome Measure Information:
Title
number of recurrences
Time Frame
Month 18
Title
time to first recurrence
Time Frame
Month 18
Title
the number of complications
Time Frame
Month 18
Title
nature of complications
Time Frame
Month 18
Title
quality of life with EQ-5D-5L
Time Frame
Month 18
Title
quality of life with SNOT 22
Time Frame
Month 18
Title
the number of hospitalizations
Time Frame
Month 18
Title
duration of hospitalizations
Time Frame
Month 18
Title
the addiction with KATZ scale
Time Frame
Month 18
Title
incremental cost-effectiveness ratio
Description
the incremental cost-effectiveness ratio (cost/number of recurrences avoided) from the perspective of the community
Time Frame
Month 18
Title
the description of the costs of care
Description
only for non-randomized patients
Time Frame
Month 18
Title
financial benefit (1 year)
Description
the annual financial benefit of routine implementation of arterial ligation in the treatment of severe epistaxis, from a community perspective
Time Frame
Month 12
Title
financial benefit (5 year)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume DE BONNECAZE, MD
Phone
0567771641
Ext
+33
Email
debonnecaze.g@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume DE BONNECAZE, MD
Organizational Affiliation
Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume DE BONNECAZE, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Medico-economic Evaluation of Management Strategies for Severe Epistaxis

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