Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease
Study Details
Study Description
Brief Summary
Randomized comparison of patient outcomes following fluoroscopic guided PCNL versus ultrasound-guided PCNL.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
This study is a randomized controlled trial that compares the operative outcomes and complications of fluoroscopic guided-percutaneous nephrolithotomy versus ultrasound-guided PCNL for renal stones. This study will be a prospective randomized controlled clinical trial with patients who have already agreed to undergo PCNL. Patients will be randomized at a 1:1 ratio to receive either PCNL under fluoroscopic guidance or PCNL under ultrasound guidance. Patients will be asked to complete pre-operative, and postoperative quality of life questionnaires, and to allow the collection of one additional vial of blood for measurement of factors associated with inflammation.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: PCNL under fluoroscopic control
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Procedure: PCNL under fluoroscopic control
Patients receive standard of care treatment for their urolithiasis using standard PCNL under fluoroscopic guidance
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Active Comparator: PCNL under ultrasound control
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Procedure: PCNL under ultrasound control
Patients receive standard of care treatment for their urolithiasis using standard PCNL under US guidance
|
Outcome Measures
Primary Outcome Measures
- Blood loss as estimated by postoperative decreases in haemoglobin [Post-operative day 1]
Secondary Outcome Measures
- Surgical outcomes [6 months]
Outcome measures by using the clavien dindo classification system
- Asses the easiness of accessibility of the targeted stone [Intraoperatively]
Outcome measures by counting numbers of puncture trial
- The Puncture fluoroscopy screening time [Intraoperatively]
assessed on the monitor of C-Arm.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients planned for PCNL at participating institution
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Patients of all ethnic backgrounds
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Stone size over 10 mm in diameter and a density over 900 Hounsfield units
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Patients with a large calculus in the upper third of the ureter
Exclusion Criteria:
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Pregnancy
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infectious disease of the genitals;
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conditions that violate the configuration of the kidneys (curvature of the spinal column)
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anomalies in the development of the kidneys with impaired configuration and position of the kidneys (horseshoe kidney, bisque kidney, S-shaped kidney, L-shaped kidney, lumbar dystopia, iliac dystopia, pelvic dystopia)
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presence of nephrostomy drainage in the target kidney;
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urethral stricture or other reason leading to the inability to carry out ureteral catheterization;
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other conditions that are contraindications to surgical treatment, such as uncontrolled diabetes mellitus, acute cardiovascular conditions, liver failure, alcoholism, and drug addiction;
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patients who are unable to understand the purpose of the study or refuse further follow-up observation and instructions after treatment;
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patients with a history of mental illness;
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participation in another research that interferes with this research;
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acute renal failure;
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dissecting aortic aneurysm;
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acute hypertensive encephalopathy;
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heavy arterial bleeding;
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myocardial infarction less than six months before enrollment in the study;
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Stroke less than six months before enrollment in the study;
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Insufficiency of blood circulation III-IV New York Heart Association class;
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Severe rhythm and conduction disturbances;
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Increase in the level of liver transaminases by more than three times;
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Astana Medical University
- Medipol University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 8