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

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.

Study Overview

• Status: Completed
• Conditions: Renal Calculi
• Intervention / Treatment: Procedure: Outpatient Recovery; Procedure: In hospital recovery

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Centre for Applied Urological Research/Kingston General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient; Outpatient recovery following Percutaneous nephrolithotomy	Procedure: Outpatient Recovery; Patients go home following Percutaneous nephrolithotomy
Sham Comparator: In hospital; Inpatient recovery following Percutaneous nephrolithotomy	Procedure: In hospital recovery; Patients are hospitalized following Percutaneous nephrolithotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To randomize and successfully treat patients with outpatient PCNL versus standard PCNL.	To randomize and successfully treat patients with outpatient PCNL versus standard PCNL.	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Is there is a difference in costs, complications and stone-free rates between the two groups.	Is there a difference in costs, complications and stone-free rates between the two groups.	One month

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Principal Investigator: Darren Beiko, MD FRCSC, Queen's University

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: September 20, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (Estimate): September 21, 2011

Study Record Updates

• Last Update Posted (Estimate): November 6, 2013
• Last Update Submitted That Met QC Criteria: November 5, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Renal Calculi; Percutaneous nephrolithotomy (PCNL)
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: PCNL Beiko