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

Primary Purpose

Renal Calculi

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Outpatient Recovery
In hospital recovery
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Calculi focused on measuring Renal Calculi, Percutaneous nephrolithotomy (PCNL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre for Applied Urological Research/Kingston General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Outpatient

In hospital

Arm Description

Outpatient recovery following Percutaneous nephrolithotomy

Inpatient recovery following Percutaneous nephrolithotomy

Outcomes

Primary Outcome Measures

To randomize and successfully treat patients with outpatient PCNL versus standard PCNL.
To randomize and successfully treat patients with outpatient PCNL versus standard PCNL.

Secondary Outcome Measures

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.

Full Information

First Posted
September 20, 2011
Last Updated
November 5, 2013
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT01437904
Brief Title
A Pilot Study Assessing The Feasibility Of Outpatient Tubeless Percutaneous Nephrolithotomy (PCNL)
Official Title
A Pilot Study Assessing The Feasibility Of Outpatient Tubeless Percutaneous Nephrolithotomy (PCNL)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Calculi
Keywords
Renal Calculi, Percutaneous nephrolithotomy (PCNL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outpatient
Arm Type
Experimental
Arm Description
Outpatient recovery following Percutaneous nephrolithotomy
Arm Title
In hospital
Arm Type
Sham Comparator
Arm Description
Inpatient recovery following Percutaneous nephrolithotomy
Intervention Type
Procedure
Intervention Name(s)
Outpatient Recovery
Intervention Description
Patients go home following Percutaneous nephrolithotomy
Intervention Type
Procedure
Intervention Name(s)
In hospital recovery
Intervention Description
Patients are hospitalized following Percutaneous nephrolithotomy
Primary Outcome Measure Information:
Title
To randomize and successfully treat patients with outpatient PCNL versus standard PCNL.
Description
To randomize and successfully treat patients with outpatient PCNL versus standard PCNL.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Is there is a difference in costs, complications and stone-free rates between the two groups.
Description
Is there a difference in costs, complications and stone-free rates between the two groups.
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren Beiko, MD FRCSC
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Applied Urological Research/Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada

12. IPD Sharing Statement

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

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