Comparing Previously Placed Nephrostomy Tract (NT) Versus Single Stage Percutaneous Nephrolithotomy (PCNL)

NCT00907946 | Terminated

• 1 other identifier: Alana Desai PCNL Study-09-0709
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis

Keywords

Renal stones

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

NT prior to PCNL

EXPERIMENTAL

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: 1. Hydronephrosis present and/or stone greater than 2cm empiric antibiotics will be initiated. 2. 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.

Procedure: NT 1 day before PCNL

NT at the surgery

NO INTERVENTION

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.

Interventions

NT 1 day before PCNL PROCEDURE

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: 1. Hydronephrosis present and/or stone greater than 2cm empiric antibiotics will be initiated. 2. 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.

NT prior to PCNL

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Minors
• Unable to understand the informed consent
• Unwilling to fill out the SF 36 questionnaire

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Urolithiasis; Nephrolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 25, 2009
• Study Start: December 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

US (1)