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Conventional Percutaneous surgery vs. Endoscopic Combined Intrarenal surgery for the treatment of large Kidney Stones

Not Applicable
Conditions
Kidney Calculi
C12.777
Registration Number
RBR-7xzcmg7
Lead Sponsor
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
Not specified
Target Recruitment
Not specified
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

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.

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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
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