Creation of an arteriovenous fistula: Patients will undergo the surgical procedure to create an arteriovenous fistula and will be discharged the same day (outpatient care, or an overnight stay in hospital if they live a long way from the hospital, have multiple pathologies or are socially isolated). An arteriovenous fistula is created under local or general anaesthetic. On the day of the operation, the type of arteriovenous fistula created, the side of the arteriovenous fistula, the location of the arteriovenous fistula and the patency of the arteriovenous fistula will be collected.
Study summary
The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years;
* Stage 5 chronic kidney disease, on dialysis or not on dialysis;
* Requiring the creation of an arteriovenous fistula;
* Membership of a social insurance scheme;
* Patient having been informed and having formulated his/her oral non-opposition to participate in the research.
Exclusion Criteria:
* Contraindication to the proposed surgery ;
* Reduced life expectancy in the opinion of the investigator;
* Medical or biological conditions which, in the opinion of the investigator, could influence the interpretation of the results of the study or the safety of the patient;
* Patient uncooperative with protocol requirements or unable to attend scheduled visits to the centre;
* Other surgical or medical intervention planned during the study;
* Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
* Participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient under guardianship or deprived of liberty.
Primary outcome measure(s)
Occurrence of ischaemia of the hand — 12 months Number and proportion of patients with ischaemia (Yes = stages 1, 2 or 3/No = stage 0) according to the preoperative American Vascular Surgery ischaemia classification :
0 - nothing
1. \- cold hand
2. \- pain on exercise and/or during dialysis
3. \- permanent pain, wound (ulceration, necrosis, gangrene)
Trial sites (1)
Facility
City
Region
Status
Hôpital Privé des Peupliers
Paris
France
Recruiting
More GCS Ramsay Santé pour l'Enseignement et la Recherche trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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