Back to resultsTubeless Versus Standard Upper Pole Percutaneous Nephrolithotomy
Primary Purpose
Pleural Effusion
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Double J stent without nephrostomy
nephrostomy tube and double J stent
Sponsored by
About this trial
This is an interventional prevention trial for Pleural Effusion focused on measuring Percutaneous Nephrolithotomy (PCNL), Nephrostomy, Double J stent, PleuraL Effusion
Eligibility Criteria
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
Sites / Locations
- Urology department, Rabin Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Nephrostomy tube + double J stent
Double J stent without nephrostomy
Arm Description
Standard therapy group with nephrostomy tube and double J stent left at the end of the PCNL
Double J stent only left at the end of the procedure
Outcomes
Primary Outcome Measures
Number of Participants with pleural effusion
Assessment and comparison of pleural effusion incidence between patients in both groups
Secondary Outcome Measures
Full Information
NCT ID
NCT02036398
First Posted
January 10, 2014
Last Updated
November 26, 2018
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02036398
Brief Title
Tubeless Versus Standard Upper Pole Percutaneous Nephrolithotomy
Official Title
Comparison of Complications Between Patients Undergoing Standard Percutaneous Nephrolithotomy With Nephrostomy Tube Placement and Tubeless Percutaneous Nephrolithotomy With Double J Stent Only Placement
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
April 7, 2017 (Actual)
Study Completion Date
April 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion
Keywords
Percutaneous Nephrolithotomy (PCNL), Nephrostomy, Double J stent, PleuraL Effusion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nephrostomy tube + double J stent
Arm Type
Active Comparator
Arm Description
Standard therapy group with nephrostomy tube and double J stent left at the end of the PCNL
Arm Title
Double J stent without nephrostomy
Arm Type
Experimental
Arm Description
Double J stent only left at the end of the procedure
Intervention Type
Device
Intervention Name(s)
Double J stent without nephrostomy
Intervention Description
Double J stent only left at the end of the procedure without placement of a nephrostomy tube
Intervention Type
Device
Intervention Name(s)
nephrostomy tube and double J stent
Intervention Description
Double J stent and nephrostomy tube left at end of procedure
Primary Outcome Measure Information:
Title
Number of Participants with pleural effusion
Description
Assessment and comparison of pleural effusion incidence between patients in both groups
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanan Goldberg, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology department, Rabin Medical Center
City
Petach Tiqva
ZIP/Postal Code
49100
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
31721407
Citation
Goldberg H, Nevo A, Shtabholtz Y, Lubin M, Baniel J, Margel D, Ehrlich Y, Lifshitz D. Tubeless supra-costal percutaneous nephrolithotomy is associated with significantly less hydrothorax: a prospective randomized clinical study. BJU Int. 2020 Feb;125(2):276-283. doi: 10.1111/bju.14950. Epub 2019 Dec 3.
Results Reference
derived
Learn more about this trial
Tubeless Versus Standard Upper Pole Percutaneous Nephrolithotomy
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