NCT04069013

Standard vs Mini-PCNL for the Treatment of Stone Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urolithiasis
• Kidney Stone
• Kidney Calculi
• Ureteral Calculi
• Kidney Diseases

Interventions

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

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-11-11
• Completion: 2025-11-11
• First posted: 2019-08-28
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States