Bilateral Percutaneous Nephrolithomy

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2023-12-31

Brief Summary

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

The purpose of this study is to determine the effective regimen for definitive surgical therapy of bilateral kidney stones. It is unknown whether patients who undergo simultaneous bilateral percutaneous nephrolithotomy (PCNL) experience improved post-operative outcomes compared to patients who have staged unilateral procedures.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Pilot Study Assessing The Feasibility Of Outpatient Tubeless Percutaneous Nephrolithotomy (PCNL)

NCT01437904

Renal Calculi

COMPLETED NA

Comparing Previously Placed Nephrostomy Tract (NT) Versus Single Stage Percutaneous Nephrolithotomy (PCNL)

NCT00907946

Urolithiasis

TERMINATED NA

Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease

NCT04606758

Urolithiasis Kidney Stone Kidney Diseases +2 more

UNKNOWN NA

Mini-PNCL vs fURS in Management of Nephrolithiasis

NCT04389853

Nephrolithiasis Kidney Stone

COMPLETED NA

Feasibility of Radiation-Free Percutaneus Nephrolithotomy for Kidney Stones

NCT06922006

Kidney Stones

ACTIVE_NOT_RECRUITING

Detailed Description

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

Purpose:

The aim of this research is to determine an effective regimen for definitive surgical therapy of bilateral kidney stones. It is unknown whether patients who undergo simultaneous bilateral percutaneous nephrolithotomy (PCNL) experience improved post-operative outcomes compared to patients who have staged unilateral procedures.

Hypothesis and Justification The gold standard for surgical management of large kidney stones is percutaneous nephrolithotomy (PCNL). A large renal stone burden has been defined as \>20mm. In addition, PCNL has improved stone-free rates for lower pole calculi \>10mm compared to alternative treatments. Guidelines encourage removal of staghorn calculi for surgical candidates (Assimos et al., 2016). Patients with bilateral large stone burdens have been managed with one of two general options: (i) a single procedure in which both kidneys are operated upon or (ii) two separate procedures in which only one kidney is addressed per procedure. However, there are no prospectively performed peer-reviewed studies directly comparing the two practices. The investigators seek to determine whether there is a significant difference in patient outcomes based on the surgical regimen chosen.

The investigators hypothesize that in comparison to unilateral PCNL (U-PCNL), simultaneous bilateral PCNL (SB-PCNL) under one anesthetic results in comparable

1. stone free rates
2. re-intervention rates for residual stones and
3. perioperative complication rates

Objectives

The objectives are:

1. To provide clinical data on outcomes following simultaneous bilateral and staged percutaneous nephrolithotomy for renal and ureteral calculi
2. To determine patient preference with respect to simultaneous versus staged PCNL

Research Design This study will be a prospective, non-randomized, multi-centre, non-blinded trial. Participants will be accrued through the Vancouver General Hospital Stone Center who have been referred for bilateral stones or have been seen in consultation for bilateral stones at the Department of Urologic Sciences and are scheduled for a percutaneous nephrolithotomy (PCNL). Consent forms and Letters of Introduction outlining the study will be given to patients by a research coordinator once the decision is made to book surgery. Patients will have at least 24 hours to decide to participate. Patients will receive surgical management for their stones in the form of PCNL. A computed tomography (CT) scan of the kidneys will be performed post-operatively by week 6 to determine if any residual stone fragments are present. Patients will be seen in follow up at 3 months in clinic after undergoing a follow up CT KUB, renal ultrasound, or KUB as necessary to evaluate stone clearance.

Conditions

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

Nephrolithiasis of Both Kidneys

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patients will be managed either with simultaneous bilateral procedures or staged unilateral procedures based on surgeon's routine practice pattern. Additional surgical interventional will be dependent on initial patient stone-free outcomes.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Simultaneous Bilateral PCNL

Patients undergo simultaneous bilateral PCNL.

Group Type ACTIVE_COMPARATOR

PCNL

Intervention Type PROCEDURE

Percutaneous Nephrolithotomy is a means of treating large kidney stone burdens.

Unilateral PCNL

Patients undergoing unilateral staged PCNL.

Group Type ACTIVE_COMPARATOR

PCNL

Intervention Type PROCEDURE

Percutaneous Nephrolithotomy is a means of treating large kidney stone burdens.

Interventions

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

PCNL

Percutaneous Nephrolithotomy is a means of treating large kidney stone burdens.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

1. Age \>18 years
2. Any patient with bilateral stone burden eligible and appropriate for PCNL procedure
3. Medically fit for definitive surgical management of stone.

Exclusion Criteria

Patients with any of the following characteristics will not be eligible for the present study:

1. Those with medical comorbidities preventing them from safely undergoing definitive surgical therapy.
2. Patients who are unable to provide informed consent.
3. Patients who are planned for alternative procedures (ureteroscopy, extracorporeal shock wave lithotripsy)
4. Anyone who is unable to give their informed consent
5. Anyone under the age of 19
6. Anyone who, in the opinion of the PI, is unfit or unsuitable to participate in the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes