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NCT02036398 Clinical Trial

Tubeless Versus Standard Upper Pole Percutaneous Nephrolithotomy

Pleural Effusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02036398
Other study ID # RMC-6405
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2013
Est. completion date April 7, 2017

Study information
Verified date November 2018
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date April 7, 2017
Est. primary completion date April 7, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Double J stent without nephrostomy
Double J stent only left at the end of the procedure without placement of a nephrostomy tube
• nephrostomy tube and double J stent
Double J stent and nephrostomy tube left at end of procedure

Locations
Country Name City State
Israel Urology department, Rabin Medical Center Petach Tiqva

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with pleural effusion Assessment and comparison of pleural effusion incidence between patients in both groups 30 days
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