Kidney Diseases Clinical Trial
Official title:
Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL Under Ultrasound Control and PCNL Under Fluoroscopic Control in the Treatment of Kidney Stones
NCT number | NCT04606758 |
Other study ID # | 8 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2020 |
Est. completion date | December 2022 |
Randomized comparison of patient outcomes following fluoroscopic guided PCNL versus ultrasound-guided PCNL.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | December 2022 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients planned for PCNL at participating institution - Patients of all ethnic backgrounds - Stone size over 10 mm in diameter and a density over 900 Hounsfield units - Patients with a large calculus in the upper third of the ureter Exclusion Criteria: - Pregnancy - infectious disease of the genitals; - conditions that violate the configuration of the kidneys (curvature of the spinal column) - 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) - presence of nephrostomy drainage in the target kidney; - urethral stricture or other reason leading to the inability to carry out ureteral catheterization; - other conditions that are contraindications to surgical treatment, such as uncontrolled diabetes mellitus, acute cardiovascular conditions, liver failure, alcoholism, and drug addiction; - patients who are unable to understand the purpose of the study or refuse further follow-up observation and instructions after treatment; - patients with a history of mental illness; - participation in another research that interferes with this research; - acute renal failure; - dissecting aortic aneurysm; - acute hypertensive encephalopathy; - heavy arterial bleeding; - myocardial infarction less than six months before enrollment in the study; - Stroke less than six months before enrollment in the study; - Insufficiency of blood circulation III-IV New York Heart Association class; - Severe rhythm and conduction disturbances; - Increase in the level of liver transaminases by more than three times; |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astana Medical University | Medipol University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood loss as estimated by postoperative decreases in haemoglobin | Post-operative day 1 | ||
Secondary | Surgical outcomes | Outcome measures by using the clavien dindo classification system | 6 months | |
Secondary | Asses the easiness of accessibility of the targeted stone | Outcome measures by counting numbers of puncture trial | Intraoperatively | |
Secondary | The Puncture fluoroscopy screening time | assessed on the monitor of C-Arm. | Intraoperatively |
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