Kidney Calculi
Conditions
Interventions
The selected patients will be randomized in a 1:1 ratio between PCNL and ECIRS groups (52 patients each group), stratified by Guy's stone score grades (20), according to a randomization table generate
Sponsors
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults aged 18 or over with kidney stones greater than 20 mm, candidates for PCNL in Barts position; Signed informed consent .
Exclusion criteria
Exclusion criteria: Impossibility to perform retrograde ureteroscopy (e.g., urinary reconstruction); Contraindications to PCNL (untreated urinary infection, uncorrected coagulopathy, ipsilateral kidney tumor, pregnancy); Concurrent ureteral stone or simultaneous bilateral approach; Uncontrolled comorbidities; Refusal to sign consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome 1: Stone free rate; acessed by CT scan, defined as no residual calculi or residual fragments up to 2mm; percentage rate in each group;Primary outcome 2: surgical success rate; acessed by CT scan, defined as residual fragments up to 4mm; percentage rate in each group | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome 1: access rate to all calyces; acessed by intraoperative nephroscopy; percentage rate in each group;Secondary outcome 2: intraoperative detection of residual fragments; acessed by intraoperative nephroscopy; percentage rate in each group;Secondary outcome 3: complication rate; acessed by the modified Clavien grading system at the end of follow up; percentage rate in each group;Secondary outcome 4: stone burden reduction; acessed by CT scan, comparing the stone volume at the begining and end of study; volume reduction (percentage) in each group | — |
Countries
Brazil
Contacts
Public ContactAnderson Pellanda
Outcome results
None listed