Tubeless Versus Standard Upper Pole Percutaneous Nephrolithotomy

November 26, 2018 updated by: Hanan Goldberg, Rabin Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach Tiqva, Israel, 49100
        • Urology department, Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nephrostomy tube + double J stent
Standard therapy group with nephrostomy tube and double J stent left at the end of the PCNL
Device: Double J stent without nephrostomy
Double J stent only left at the end of the procedure without placement of a nephrostomy tube
Device: nephrostomy tube and double J stent
Double J stent and nephrostomy tube left at end of procedure
Experimental: Double J stent without nephrostomy
Double J stent only left at the end of the procedure
Device: Double J stent without nephrostomy
Double J stent only left at the end of the procedure without placement of a nephrostomy tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with pleural effusion
Time Frame: 30 days
Assessment and comparison of pleural effusion incidence between patients in both groups
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

April 7, 2017

Study Completion (Actual)

April 7, 2017

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 15, 2014

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMC-6405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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