Tubeless Versus Standard Upper Pole Percutaneous Nephrolithotomy

NCT ID: NCT02036398

Last Updated: 2018-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-04-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pleural Effusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nephrostomy tube + double J stent

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

Group Type ACTIVE_COMPARATOR

Double J stent without nephrostomy

Intervention Type DEVICE

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

nephrostomy tube and double J stent

Intervention Type DEVICE

Double J stent and nephrostomy tube left at end of procedure

Double J stent without nephrostomy

Double J stent only left at the end of the procedure

Group Type EXPERIMENTAL

Double J stent without nephrostomy

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Double J stent without nephrostomy

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

Intervention Type DEVICE

nephrostomy tube and double J stent

Double J stent and nephrostomy tube left at end of procedure

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hanan Goldberg

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hanan Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Urology department, Rabin Medical Center

Petach Tiqva, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31721407 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RMC-6405

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

High Supracostal Versus Subcostal Puncture in Adult PCNL
NCT06350045 ACTIVE_NOT_RECRUITING PHASE4