ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01437904
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : November 6, 2013
Sponsor:
Information provided by (Responsible Party):
Darren Beiko, Queen's University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Calculi Procedure: Outpatient Recovery Procedure: In hospital recovery Not Applicable

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  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study Assessing The Feasibility Of Outpatient Tubeless Percutaneous Nephrolithotomy (PCNL)
Study Start Date : March 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. To randomize and successfully treat patients with outpatient PCNL versus standard PCNL. [ Time Frame: One month ]
    To randomize and successfully treat patients with outpatient PCNL versus standard PCNL.


Secondary Outcome Measures :
  1. Is there is a difference in costs, complications and stone-free rates between the two groups. [ Time Frame: One month ]
    Is there a difference in costs, complications and stone-free rates between the two groups.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437904


Locations
Canada, Ontario
Centre for Applied Urological Research/Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Darren Beiko, MD FRCSC Queen's University

Responsible Party: Darren Beiko, Principal Investigator and Associate Professor, Queen's University
ClinicalTrials.gov Identifier: NCT01437904     History of Changes
Other Study ID Numbers: PCNL Beiko
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013

Keywords provided by Darren Beiko, Queen's University:
Renal Calculi
Percutaneous nephrolithotomy (PCNL)

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi