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

NCT ID: NCT01437904

Last Updated: 2013-11-06

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-03-31

Brief Summary

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Outpatient tubeless Percutaneous nephrolithotomy (PCNL) could potentially improve patient care and result in significant cost savings for our hospital each year. If this pilot study is successful, Queen's/KGH will lead a collaborative national multicentre trial to further establish the role of this new approach in the surgical treatment of kidney stones.

Detailed Description

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One in eight human beings will develop kidney stones during their lifetime. Percutaneous nephrolithotomy (PCNL) is the standard minimally invasive surgical operation for the removal of large kidney stones. Around the world, patients are routinely admitted to hospital following PCNL. The reasons that outpatient PCNL has not been otherwise attempted are related to the risk of bleeding and the need for an indwelling kidney drainage tube. Other than a single publication from the mid-1980's, there have been no other publications regarding outpatient PCNL up until this year, both from our group at Queen's University. We challenge the need for hospitalization following PCNL provided that proper technique for percutaneous renal access is used and patients are very carefully selected. In fact, we have safely performed outpatient tubeless PCNL on over 5 patients to date and we have two related published abstracts that were presented in 2008 at international Urology conferences in Albuquerque, New Mexico and Shanghai, China. Our manuscript titled "Totally tubeless outpatient percutaneous nephrolithotomy: initial case report" has been published in Advances in Urology in 2009. Additionally, a second manuscript of ours titled "Outpatient tubeless PCNL: the initial case series" is currently in press in the Canadian Urological Association Journal.

Outpatient PCNL offers patients several potential benefits, including decreased pain due to lack of nephrostomy tube, earlier and faster convalescence and lower rate of hospital acquired infections and complications. Furthermore, outpatient PCNL may offer several potential cost savings to the hospital and health care system, including the daily cost of an inpatient hospital bed, the imaging and procedural costs of antegrade nephrostogram, including the interventional radiologist's fee, the cost of nursing staff and the cost of intravenous antibiotics and other medications required by the hospitalized patient. Conversely, outpatient PCNL could potentially result in additional costs if emergency visits, readmissions and further interventions occur.

Project Synopsis This project is a pilot study that examines the safety, efficacy, feasibility and potential cost savings of performing percutaneous nephrolithotomy (PCNL) on an outpatient basis. If shown to be feasible, outpatient PCNL could result in significant potential cost savings to the hospital and health care system, as normal care following PCNL involves a 1-3 day hospital stay. The main objective of this pilot study is to obtain preliminary data necessary to develop a definitive national multicentre prospective randomized controlled trial comparing outpatient PCNL to standard PCNL.

Hypotheses Patients can be successfully randomized to outpatient versus standard PCNL and that outpatient PCNL will be a successful procedure.

Conditions

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Renal Calculi

Keywords

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Renal Calculi Percutaneous nephrolithotomy (PCNL)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Outpatient

Outpatient recovery following Percutaneous nephrolithotomy

Group Type EXPERIMENTAL

Outpatient Recovery

Intervention Type PROCEDURE

Patients go home following Percutaneous nephrolithotomy

In hospital

Inpatient recovery following Percutaneous nephrolithotomy

Group Type SHAM_COMPARATOR

In hospital recovery

Intervention Type PROCEDURE

Patients are hospitalized following Percutaneous nephrolithotomy

Interventions

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Outpatient Recovery

Patients go home following Percutaneous nephrolithotomy

Intervention Type PROCEDURE

In hospital recovery

Patients are hospitalized following Percutaneous nephrolithotomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* scheduled for Percutaneous nephrolithotomy (PCNL) of renal calculi
* patient has normal renal function
* patient is 18 or older
* patient agrees to return for follow up
* ASA class 1 or 2

Exclusion Criteria

* patient has had previous PCNL for same stone
* patient is pregnant
* patient would not be appropriate as participant (investigator's opinion)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Darren Beiko

Principal Investigator and Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Darren Beiko, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

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Centre for Applied Urological Research/Kingston General Hospital

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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PCNL Beiko

Identifier Type: -

Identifier Source: org_study_id