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| Name | Class |
|---|---|
| Euraxi Pharma | INDUSTRY |
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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.
This is a non-interventional, prospective, non-randomised, descriptive, single-centre study with no comparator.
The study population will be adult patients with chronic renal failure for whom an arteriovenous fistula has been planned.
Patients requiring the creation of an arteriovenous fistula by the surgeons at Hôpital Privé des Peupliers will be seen beforehand in the usual pre-operative consultation, during which the surgeon will explain the principle of the operation and the expected benefits/risks. On the day of surgery, patients will undergo the surgical procedure to create an arteriovenous fistula and will be discharged the same day. Patients will be reviewed during post-operative follow-up visits at 1, 6 and 12 months as in standard practice. All the data collected in the study were collected in routine medical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with chronic renal failure | Adult patients with chronic renal failure for whom arteriovenous fistula creation is planned |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Creation of an arteriovenous fistula | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of ischaemia of the hand | 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
| 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be adult patients suffering from chronic renal failure for whom the creation of an arteriovenous fistula is planned.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viviane DUEDAL, MD | Contact | 6 70 80 18 98 | +33 | v.duedal@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé des Peupliers | Recruiting | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |