Standard vs Mini-PCNL for the Treatment of Stone Disease

The Cleveland Clinic18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Urolithiasis Kidney Stone Kidney Calculi Ureteral Calculi Kidney Diseases

Interventions

PCNLPROCEDURE

Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: Post-operative day 1

Secondary Outcomes

Surgical outcomes

Discharge time

Time frame: 30 Days

Complication Rates

Time frame: 30 Days

Renal Pelvis Pressures

Intraoperative renal pelvis pressures

Time frame: Intraoperative

Procalcitonin- Inflammatory Markers

Procalcitonin

Time frame: Post operative day 1

IL-6 Inflammatory Markers

IL-6

Time frame: Post operative day 1

Data from ClinicalTrials.gov

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