Urolithiasis, Kidney Stone, Kidney Calculi, Ureteral Calculi, Kidney Diseases
Conditions
Keywords
Percutaneous Nephrolithotomy, PCNL
Brief summary
Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.
Detailed description
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.
Interventions
PROCEDUREPCNL
Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL
Sponsors
University of British Columbia
Massachusetts General Hospital
Vanderbilt University Medical Center
Duke University
Ohio State University
Columbia University
Dartmouth-Hitchcock Medical Center
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical outcomes | 30 Days | Discharge time |
| Complication Rates | 30 Days | Complication Rates |
| Renal Pelvis Pressures | Intraoperative | Intraoperative renal pelvis pressures |
| Procalcitonin- Inflammatory Markers | Post operative day 1 | Procalcitonin |
| IL-6 Inflammatory Markers | Post operative day 1 | IL-6 |
Countries
United States
Outcome results
None listed