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临床试验/NCT01437904
NCT01437904已完成不适用

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

Queen's University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
To randomize and successfully treat patients with outpatient PCNL versus standard PCNL.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

In hospital

Sham Comparator

Inpatient recovery following Percutaneous nephrolithotomy

干预措施: In hospital recovery (Procedure)

Outpatient

Experimental

Outpatient recovery following Percutaneous nephrolithotomy

干预措施: Outpatient Recovery (Procedure)

结局指标

主要结局

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

时间窗: One month

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

次要结局

  • Is there is a difference in costs, complications and stone-free rates between the two groups.(One month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Darren Beiko

Principal Investigator and Associate Professor

Queen's University

研究点 (1)

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