N/A
N=450
A Prospective Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy
Urolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT02266381 ↗Enrolled (actual)
450
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Stone Free Rate — 81; 91; 98 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- US-guided renal access (Procedure); Fluoroscopy-guided renal access (Procedure); US combined with fluoroscopy-guided renal access (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stone Free Rate |
81; 91; 98 | — |
| SECONDARY Perioperative Complications |
17; 31; 20 | — |
| SECONDARY Operation Time |
60.6; 63.6; 66.3 | — |
| SECONDARY Change in Hemoglobin Concentration |
12.9; 14.5; 13.1 | — |
Summary
Purpose:
The aim of this present study is to compare the result of fluoroscopy, ultrasonography (US) and US combined with fluoroscopy in the guidance of minimally invasive percutaneous nephrolithotomy (MPCNL).
Methods:
The investigators will enroll 450 patients who are candidates for MPCNL in our study. By simple random sampling technique, patients will be assigned to three 150-patient groups (group 1, US-guided MPCNL, group 2, fluoroscopy-guided MPCNL and group 3, US combined with fluoroscopy-guided MPCNL). In addition to approaches in guidance of MPCNL, the rest of the procedure is the same in all three groups.The end point of the study is the comparison of outcome of procedure including stone free rate, transfusion rate, operation time, access time, length of stay and complications.
Eligibility Criteria
Inclusion Criteria
- Normal renal function.
- American society of Anesthesiology (ASA) score 1 and 2.
- Absence of congenital abnormalities.
- Kidney stones of diameter > 2.0cm (including multiple and staghorn stones)
Exclusion Criteria
- Patients with congenital anomalies, e.g. ectopic kidney, polycystic, horseshoe, or malrotated kidney.
- Patients who underwent transplant or urinary diversion.
- Patients with solitary kidney.
- Patients will be excluded from the study if they undergoing MPCNL have purulent fluid in the initial puncture.
Data sourced from ClinicalTrials.gov (NCT02266381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.