McMaster Catheterization for Thoracoscopic Surgery Study (UCATh)

A Prospective Randomized Control Trial Comparing Routine Urinary Catheterization vs. No-Urinary Catheterization at the Time of Thoracoscopic Pulmonary Resection (McMaster Catheterization for Thoracoscopic Surgery Study - UCATh Study)

It is common practice to insert a Foley catheter into the bladder to drain urine during and after a lung resection. Recently, there has been increasing interest in the potential risks associated with this catheterization, particularly with regard to infection. As thoracic surgery adopts minimally invasive surgical techniques, the need for urinary catheterization during surgery is being questioned since these less invasive surgeries are known to result in less post-operative acute pain, shorter length of stay, and other outcomes that tend to decrease overall anesthetic needs for this patient population. Thus, there is a need to investigate whether patients who have had a minimally invasive lung resection truly need the Foley catheter at all. This will be achieved by assigning patients to either an experimental no-catheter group or the standard of care routine urinary catheter group to determine if patients with no catheter experience different rates of complications. This pilot study will primarily determine if there is a difference in post operative urinary complications between the groups. It is hoped that this study will definitively determine whether a Foley urine catheter is a necessary procedure in the course of a minimally invasive lung resection.

Study Overview

• Status: Withdrawn
• Conditions: Lung Neoplasms; Non-Small Cell Lung Cancer; Urinary Tract Infections; Metastatic Lung Cancer; Urinary Retention
• Intervention / Treatment: Other: No Foley Urinary Catheter; Other: Standard of care Foley urinary catheter insertion

Detailed Description

Urinary catheterization is standard practice during and shortly after lung resections. The standard practice is being questioned in an era where unnecessary interventions are being re-considered, particularly since urinary catheterization is not without a risk of adverse events. The study is being done to establish an evidence base to support widespread discontinuation or continuation of this standard practice. Consenting patients will be randomized to either the catheterized or non-catheterized arms. Patient urinary management will be managed as per an a priori-defined protocol that follows St. Joseph's Healthcare Hamilton (SJHH) institutional standards.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must undergo minimally invasive Video-Assisted Thoracoscopic Thoracic Surgery (VATS) or Robotic-Assisted Thoracoscopic Thoracic Surgery (RTS) anatomic pulmonary resection surgery (lobectomy, segmentectomy)
• Must be diagnosed with primary or secondary lung cancer eligible for resection

Exclusion Criteria:

• Patients who are unwilling to comply with study procedures
• Patients who are unable to complete questionnaires with assistance
• Non-VATS/RTS pulmonary resection patients
• Non-anatomic pulmonary resection
• Patients with benign disease
• Patients requiring chronic urinary catheterization
• Patients with contraindications to placement of urinary catheter

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator; The catheterized arm will have Standard of care Foley urinary catheter insertion according to usual institutional care pathways in the operating room prior to surgery initiation. The urinary catheter will be assessed for removal on the morning of post-operative day 1, and patients will be monitored for urinary complications once catheter is removed until patient has successfully voided spontaneously within 8 +/- 2 hours.	Other: No Foley Urinary Catheter; No Foley urinary catheter will be put in place during the operation; Other Names: Experimental Comparator
Experimental: Experimental Arm; The non-catheterized arm will have standard of care Foley urinary catheter insertion, with no Foley Urinary Catheter inserted prior to, during, or after surgery unless the patient is showing signs of urinary retention after surgery. Patient will be monitored for urinary complications starting in the recovery room until patient has successfully voided spontaneously within 8 +/- 2 hours	Other: Standard of care Foley urinary catheter insertion; A Foley urinary catheter will be put in place during the operation; Other Names: Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative urinary complications	Compating the difference in the rate of the occurrence of one or more of postoperative urinary tract infection, postoperative urinary retention requiring 1 catheterization, and postoperative urinary retention requiring more than 1 catheterization between the catheterized and the non-catheterized arms	From the time of surgery to post-operative Day 14.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	Comparing the total length of hospital stay between the catheterized and non-catheterized arms	During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Rate of Post-operative Hypotension	Post-operative hypotension will be defined as systolic blood pressure less than 80 mmHg for > 6 hours requiring active fluid resuscitation. The comparison will be made of rate of occurrence between the catheterized and non-catheterized arms to account for varied volumes of fluid intake that may confound observations	During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Total IV fluid administration	The comparison will be made of rate of occurrence between the catheterized and non-catheterized arms to account for varied volumes of fluid intake that may confound observations	First 48 hours of the perioperative period
Validity of the bladder scanner tool relative to actual urine output	In patients who underwent a bladder scan for suspected urinary retention (Failure to pass urine within 8 +/-2 hours of de-catheterization or after surgery), it is necessary to measure how accurate the bladder scan procedure is relative to the actual amount of urine in the bladder. The bladder scanner will generate an estimate of the amount of urine in the bladder, but the accuracy is not known. The volume of urine collected from the catheter by nursing staff or as measured from a urine collection hat and compared to the reading from the bladder scanner	During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Rate of peri-operative pulmonary complications	Pulmonary complications defined as Grade II or greater according to the Ottawa Thoracic Morbidity and Mortality (TM&M) scale (requiring treatment). The comparison will be made of rate of complication occurrence between the catheterized and non-catheterized arms	During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Rate of peri-operative cardiac complications	Cardiac complications defined as Grade I or greater according to the Ottawa Thoracic Morbidity and Mortality (TM&M) scale (no treatment required). The comparison will be made of rate of complication occurrence between the catheterized and non-catheterized arms	During patient hospital stay (Estimated to be between post-operative day 0 and day 7)

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: John Agzarian, MD, MPH, FRCSC, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 28, 2015

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Quality Improvement; Post-operative complications; Evidence-Based Practice; Thoracic Surgery, Video-Assisted; Urinary Catheterization
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Urologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Urination Disorders; Lung Neoplasms; Urinary Tract Infections; Urinary Retention
• Other Study ID Numbers: SJHH_UCATh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No