NCT02036398

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2017

Completed
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

4.3 years

First QC Date

January 10, 2014

Last Update Submit

November 26, 2018

Conditions

Pleural Effusion

Keywords

Percutaneous Nephrolithotomy (PCNL)NephrostomyDouble J stentPleuraL Effusion

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with pleural effusion

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

    30 days

Study Arms (2)

Nephrostomy tube + double J stent

ACTIVE COMPARATOR

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

Device: Double J stent without nephrostomyDevice: nephrostomy tube and double J stent

Double J stent without nephrostomy

EXPERIMENTAL

Double J stent only left at the end of the procedure

Device: Double J stent without nephrostomy

Interventions

Double J stent without nephrostomyDEVICE

Double J stent only left at the end of the procedure without placement of a nephrostomy tube

Double J stent without nephrostomyNephrostomy tube + double J stent
nephrostomy tube and double J stentDEVICE

Double J stent and nephrostomy tube left at end of procedure

Nephrostomy tube + double J stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology department, Rabin Medical Center

Petach Tiqva, 49100, Israel

Location

Related Publications (1)

  • 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.

    PMID: 31721407DERIVED

MeSH Terms

Conditions

Pleural Effusion

Interventions

Nephrotomy

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Hanan Goldberg, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 15, 2014

Study Start

January 1, 2013

Primary Completion

April 7, 2017

Study Completion

April 7, 2017

Last Updated

November 28, 2018

Record last verified: 2018-11

Locations

IL(1)