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Clinical Trials/NCT02036398
NCT02036398CompletedNot Applicable

Comparison of Complications Between Patients Undergoing Standard Percutaneous Nephrolithotomy With Nephrostomy Tube Placement and Tubeless Percutaneous Nephrolithotomy With Double J Stent Only Placement

Rabin Medical Center2 sites in 1 country75 target enrollmentStarted: January 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
75
Locations
2
Primary Endpoint
Number of Participants with pleural effusion

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Nephrostomy tube + double J stent

Active Comparator

Standard therapy group with nephrostomy tube and double J stent left at the end of the PCNL

Intervention: nephrostomy tube and double J stent (Device)

Nephrostomy tube + double J stent

Active Comparator

Standard therapy group with nephrostomy tube and double J stent left at the end of the PCNL

Intervention: Double J stent without nephrostomy (Device)

Double J stent without nephrostomy

Experimental

Double J stent only left at the end of the procedure

Intervention: Double J stent without nephrostomy (Device)

Outcomes

Primary Outcomes

Number of Participants with pleural effusion

Time Frame: 30 days

Assessment and comparison of pleural effusion incidence between patients in both groups

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hanan Goldberg

MD

Rabin Medical Center

Study Sites (2)

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