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

NCT01437904 | Completed

• 1 other identifier: PCNL Beiko
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Calculi

Keywords

Renal Calculi; Percutaneous nephrolithotomy (PCNL)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  One month

Study Arms (2)

Outpatient

EXPERIMENTAL

Outpatient recovery following Percutaneous nephrolithotomy

Procedure: Outpatient Recovery

In hospital

SHAM COMPARATOR

Inpatient recovery following Percutaneous nephrolithotomy

Procedure: In hospital recovery

Interventions

Outpatient Recovery PROCEDURE

Patients go home following Percutaneous nephrolithotomy

Outpatient

In hospital recovery PROCEDURE

Patients are hospitalized following Percutaneous nephrolithotomy

In hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Centre for Applied Urological Research/Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Darren Beiko, MD FRCSC

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Associate Professor

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 21, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: November 6, 2013

Record last verified: 2013-11

Locations

CA (1)