Kidney Diseases Clinical Trial
Official title:
Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL and Mini PCNL in the Treatment of Kidney Stones
NCT number | NCT04069013 |
Other study ID # | 19-589 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | April 30, 2024 |
Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | April 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients planned for PCNL at participating institutions - Age = 18 years old - Male and female patients - Patients of all ethnic backgrounds - Stone size 10-20mm Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study. Exclusion Criteria: - Conversion to open procedure - Multiple access tracts - Anticoagulated or history of coagulopathy - Preoperative ureteral stent or nephrostomy tube placement - Technical problems/impossibility of localizing the stone on the day of intervention Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic | Columbia University, Dartmouth-Hitchcock Medical Center, Duke University, Massachusetts General Hospital, Ohio State University, University of British Columbia, Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss | 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 | Post-operative day 1 | |
Secondary | Surgical outcomes | Discharge time | 30 Days | |
Secondary | Complication Rates | Complication Rates | 30 Days | |
Secondary | Renal Pelvis Pressures | Intraoperative renal pelvis pressures | Intraoperative | |
Secondary | Procalcitonin- Inflammatory Markers | Procalcitonin | Post operative day 1 | |
Secondary | IL-6 Inflammatory Markers | IL-6 | Post operative day 1 |
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