Back to resultsComparing Previously Placed Nephrostomy Tract (NT) Versus Single Stage Percutaneous Nephrolithotomy (PCNL)
Primary Purpose
Urolithiasis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NT 1 day before PCNL
Sponsored by
About this trial
This is an interventional prevention trial for Urolithiasis focused on measuring Renal stones
Eligibility Criteria
Inclusion Criteria:
- Patients age 18 years to 90 years old,
- Patients with stone disease
- Patients who hoose to have PCNL for treatment
- Patients who understand the informed consent
Exclusion Criteria:
- Minors
- Unable to understand the informed consent
- Unwilling to fill out the SF 36 questionnaire
Sites / Locations
- Washington University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NT prior to PCNL
NT at the surgery
Arm Description
A bladder urine culture will be obtained prior to nephrostomy tube placement and antibiotic treatment will be initiated if necessary. A nephrostomy tube will be placed at least one week prior to surgery in the Vascular Interventional Radiology (VIR) suite under fluoroscopic or ultrasound guidance. The type of imaging will be determined by the radiologist at the time of procedure and documented. A renal pelvis urine culture will be obtained at the time of nephrostomy tube placement. If the culture is positive, the patients will be treated with appropriate antibiotics for at least one week prior to PCNL. If the culture is negative, the patient will be stratified into 2 groups: Hydronephrosis present and/or stone greater than 2cm empiric antibiotics will be initiated. If neither of the above criteria (a.) are met, and the urine culture is negative, no antibiotics will be administered except peri-operatively according to standard protocol.
A bladder urine culture will be obtained prior to surgery and appropriate antibiotic treatment will be initiated if necessary. The nephrostomy tract will be placed at the time of surgery under fluoroscopic guidance. All patients will receive empiric intravenous peri-operative antibiotics at induction. Renal pelvis urine and stone will be collected for culture and post-operative treatment will be initiated if necessary.
Outcomes
Primary Outcome Measures
Reduction of complications related to bleeding and infection
We aim to determine whether placement of a nephrostomy tube prior to definitive stone surgery and under ultrasonic or fluoroscopic guidance will reduce complications related to bleeding and infection compared to obtaining renal access at the time of surgery.
Secondary Outcome Measures
Full Information
NCT ID
NCT00907946
First Posted
May 21, 2009
Last Updated
January 9, 2019
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00907946
Brief Title
Comparing Previously Placed Nephrostomy Tract (NT) Versus Single Stage Percutaneous Nephrolithotomy (PCNL)
Official Title
A Prospective, Randomized Trial Comparing Previously Placed Nephrostomy Tract and Single Stage Percutaneous Nephrolithotomy and Its Effects on Infection and Bleeding Related Complications
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators are trying to determine whether placement of a nephrostomy tube prior to definitive stone surgery and under ultrasonic or fluoroscopic guidance will reduce complications related to bleeding and infection compare to obtaining renal access at the time of surgery.
Detailed Description
We seek to identify whether the placement of a nephrostomy tract prior to surgery versus at the time of PCNL will: 1. decrease blood loss and related complications, and 2. decrease infection-related complications by providing the ability to an accurate collection of urine for culture and initiating appropriate antibiotic treatment prior to definitive stone management. In addition, we seek to determine whether renal puncture under fluoroscopic vs ultrasonic guidance is associated with less blood loss. Although retrospective studies have shown some benefit to placing the nephrostomy tube prior to surgery in terms of decreased blood loss, there are no well-designed, prospective studies comparing the two treatment approaches. We seek to determine which treatment approach is safer, more efficacious, and more cost-effective through a prospective, randomized trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
Renal stones
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NT prior to PCNL
Arm Type
Experimental
Arm Description
A bladder urine culture will be obtained prior to nephrostomy tube placement and antibiotic treatment will be initiated if necessary. A nephrostomy tube will be placed at least one week prior to surgery in the Vascular Interventional Radiology (VIR) suite under fluoroscopic or ultrasound guidance. The type of imaging will be determined by the radiologist at the time of procedure and documented. A renal pelvis urine culture will be obtained at the time of nephrostomy tube placement. If the culture is positive, the patients will be treated with appropriate antibiotics for at least one week prior to PCNL. If the culture is negative, the patient will be stratified into 2 groups:
Hydronephrosis present and/or stone greater than 2cm empiric antibiotics will be initiated.
If neither of the above criteria (a.) are met, and the urine culture is negative, no antibiotics will be administered except peri-operatively according to standard protocol.
Arm Title
NT at the surgery
Arm Type
No Intervention
Arm Description
A bladder urine culture will be obtained prior to surgery and appropriate antibiotic treatment will be initiated if necessary. The nephrostomy tract will be placed at the time of surgery under fluoroscopic guidance. All patients will receive empiric intravenous peri-operative antibiotics at induction. Renal pelvis urine and stone will be collected for culture and post-operative treatment will be initiated if necessary.
Intervention Type
Procedure
Intervention Name(s)
NT 1 day before PCNL
Intervention Description
A bladder urine culture will be obtained prior to nephrostomy tube placement and antibiotic treatment will be initiated if necessary. A nephrostomy tube will be placed at least one day prior to surgery in the Vascular Interventional Radiology (VIR) suite under fluoroscopic or ultrasound guidance. The type of imaging will be determined by the radiologist at the time of procedure and documented. A renal pelvis urine culture will be obtained at the time of nephrostomy tube placement. If the culture is positive, the patients will be treated with appropriate antibiotics for at least one week prior to PCNL. If the culture is negative, the patient will be stratified into 2 groups:
Hydronephrosis present and/or stone greater than 2cm empiric antibiotics will be initiated.
If neither of the above criteria (a.) are met, and the urine culture is negative, no antibiotics will be administered except peri-operatively according to standard protocol.
Primary Outcome Measure Information:
Title
Reduction of complications related to bleeding and infection
Description
We aim to determine whether placement of a nephrostomy tube prior to definitive stone surgery and under ultrasonic or fluoroscopic guidance will reduce complications related to bleeding and infection compared to obtaining renal access at the time of surgery.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients age 18 years to 90 years old,
Patients with stone disease
Patients who hoose to have PCNL for treatment
Patients who understand the informed consent
Exclusion Criteria:
Minors
Unable to understand the informed consent
Unwilling to fill out the SF 36 questionnaire
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparing Previously Placed Nephrostomy Tract (NT) Versus Single Stage Percutaneous Nephrolithotomy (PCNL)
We'll reach out to this number within 24 hrs