Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
NCT Number: NCT04069013
Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
This study is a randomized controlled trial which compares the operative outcomes and complications of mini-percutaneous nephrolithotomy (mini-PCNL) versus standard PCNL for renal stones. This study will be a multi-institutional, 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 standard PCNL or mini-PCNL, defined as tract sizes of 30 and 16.5 to 18 French respectively. Patients will be asked to complete pre-operative, and post-operative quality of life questionnaires, and to allow collection of one additional vial of blood for measurement of factors associated with inflammation. The participating institutions are academic medical centers in the United States and Canada that are part of the EDGE research consortium.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.
Exclusion criteria
Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.
Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL
Time frame: Post-operative day 1
Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Post-op decreases in hemoglobin
Time frame: 30 Days
Discharge time
Time frame: 30 Days
Complication Rates
Time frame: Intraoperative
Intraoperative renal pelvis pressures
Time frame: Post operative day 1
Procalcitonin
Time frame: Post operative day 1
IL-6
The Cleveland Clinic
Other
Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL and Mini PCNL in the Treatment of Kidney Stones
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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