Urological complications following renal transplantation Urological and Genital Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects freely giving their consent 2. Adult recipients of a kidney transplant from a living donor or a deceased donor (donation after brain death [DBD] or donation after circulatory death [DCD])
Exclusion criteria
Exclusion criteria: 1. Multi-organ transplant recipients such as heart-kidney, liver-kidney and small bowel-kidney transplants (but not simultaneous pancreas-kidney [SPK] transplants). 2. Renal transplant recipients in whom the donor ureter is not anastomosed to the recipient bladder (e.g., anastomosed onto the native ureter or an ileal conduit) 3. Recipients of double kidney transplants 4. Recipients of kidneys with two ureters
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of incidence of UTI and ureteric complications (urine leaks or ureteric stenosis) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of UTIs (symptomatic and asymptomatic bacteriuria considered separately) 2. Incidence of urine leak 3. Incidence of ureteric stenosis 4. Patient death 5. Graft loss 6. Surgical complications (renal vein thrombosis, renal artery thrombosis, bleeding, lymphocoele, wound infection, re-operation, urinary retention) 7. Immunological complications (delayed graft function, rejection) 8. Re-admission and duration of inpatient stay 9. Medical complications (myocardial infarction, deep vein thrombosis, pulmonary embolism, new onset diabetes after transplantation [NODAT]) All outcomes (primary and secondary) will be measured at 3 months post transplantation. The outcomes include rates of complications (e.g., urine leak, ureteric stenosis and urinary tract infections). All data will be obtained from a prospectively maintained database and the diagnosis of these complications will be based on standard clinical criteria. | — |
Countries
United Kingdom