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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00907946
Other study ID # Alana Desai PCNL Study-09-0709
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 2009
Est. completion date October 2010

Study information

Verified date January 2019
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
NT 1 day before PCNL
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.

Locations

Country Name City State
United States Washington University Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 years
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