Standard vs Mini-PCNL for the Treatment of Stone Disease

Study Overview
=================
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.

Official Title
-----------------
Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL and Mini PCNL in the Treatment of Kidney Stones

Conditions
-----------------
Urolithiasis, Kidney Stone, Kidney Calculi, Ureteral Calculi, Kidney Diseases

Intervention / Treatment
-----------------
* Procedure: PCNL


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard PCNL<br>Patients receive a standard PCNL procedure using a 24 fr tract | Procedure: PCNL<br>* Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL<br>|
| Active Comparator: Mini-PCNL<br>Patients receive a mini-PCNL procedure using a 16 fr tract | Procedure: PCNL<br>* Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical outcomes | Discharge time | 30 Days | 
| Complication Rates | Complication Rates | 30 Days | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous Nephrolithotomy, PCNL