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| Name | Class |
|---|---|
| University of British Columbia | OTHER |
| Massachusetts General Hospital | OTHER |
| Vanderbilt University Medical Center | OTHER |
| Duke University |
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Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard PCNL | Active Comparator | Patients receive a standard PCNL procedure using a 24 fr tract |
|
| Mini-PCNL | Active Comparator | Patients receive a mini-PCNL procedure using a 16 fr tract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCNL | Procedure | Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical outcomes | Discharge time | 30 Days |
| Complication Rates | Complication Rates | 30 Days |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Manoj Monga, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D007669 | Kidney Calculi |
| D014514 | Ureteral Calculi |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| OTHER |
| Ohio State University | OTHER |
| Columbia University | OTHER |
| Dartmouth-Hitchcock Medical Center | OTHER |
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| Renal Pelvis Pressures | Intraoperative renal pelvis pressures | Intraoperative |
| Procalcitonin- Inflammatory Markers | Procalcitonin | Post operative day 1 |
| IL-6 Inflammatory Markers | IL-6 | Post operative day 1 |
| D052801 | Male Urogenital Diseases |
| D053040 | Nephrolithiasis |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D053039 | Ureterolithiasis |
| D014515 | Ureteral Diseases |