Tubeless Versus Standard Upper Pole Percutaneous Nephrolithotomy

Not Applicable

Completed

• Conditions: Pleural Effusion
• Interventions: Device: Double J stent without nephrostomy; Device: nephrostomy tube and double J stent

• Registration Number: NCT02036398
• Lead Sponsor: Rabin Medical Center

Brief Summary

Comparison of complications between standard upper pole percutaneous nephrolithotomy (PCNL) with nephrostomy placement and double J stent and PCNL with double J placement only without nephrostomy.

Detailed Description

Measurement of complications in and comparison between two groups of patients undergoing upper pole PCNL. First group consists of patients left with nephrostomy and double J stent and the second group includes patients left with double J stent only without nephrostomy.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-15
• Primary Completion: 2017-04-07
• Study Completion: 2017-04-07
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-26
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Patients undergoing upper pole percutaneous nephrolithotomy older than 18 years of age and willing to participate

Exclusion Criteria

• Patients younger than 18 years of age
• Patients unwilling to participate in the study
• Patients that nephrostomy tube placement was a prerequisite at the end of the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nephrostomy tube + double J stent	nephrostomy tube and double J stent	Standard therapy group with nephrostomy tube and double J stent left at the end of the PCNL
Nephrostomy tube + double J stent	Double J stent without nephrostomy	Standard therapy group with nephrostomy tube and double J stent left at the end of the PCNL
Double J stent without nephrostomy	Double J stent without nephrostomy	Double J stent only left at the end of the procedure

Primary Outcome Measures

Name	Time	Method
Number of Participants with pleural effusion	30 days	Assessment and comparison of pleural effusion incidence between patients in both groups

Trial Locations

Locations (1)

Urology department, Rabin Medical Center; 🇮🇱 Petach Tiqva, Israel