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McMaster Catheterization for Thoracoscopic Surgery Study (UCATh)

Primary Purpose

Non-Small Cell Lung Cancer, Lung Neoplasms, Metastatic Lung Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
No Foley Urinary Catheter
Standard of care Foley urinary catheter insertion
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-Small Cell Lung Cancer focused on measuring Urinary Catheterization, Randomized Controlled Trial, Thoracic Surgery, Video-Assisted, Quality Improvement, Evidence-Based Practice, Post-operative complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Active Comparator

Experimental Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of Hospital Stay
Comparing the total length of hospital stay between the catheterized and non-catheterized arms
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
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
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
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
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

Full Information

First Posted
December 22, 2015
Last Updated
December 19, 2018
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT02640326
Brief Title
McMaster Catheterization for Thoracoscopic Surgery Study
Acronym
UCATh
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Research question no longer useful/feasible due to shifts in standards of care
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer, Lung Neoplasms, Metastatic Lung Cancer, Urinary Retention, Urinary Tract Infections
Keywords
Urinary Catheterization, Randomized Controlled Trial, Thoracic Surgery, Video-Assisted, Quality Improvement, Evidence-Based Practice, Post-operative complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
No Foley Urinary Catheter
Other Intervention Name(s)
Experimental Comparator
Intervention Description
No Foley urinary catheter will be put in place during the operation
Intervention Type
Other
Intervention Name(s)
Standard of care Foley urinary catheter insertion
Other Intervention Name(s)
Active Comparator
Intervention Description
A Foley urinary catheter will be put in place during the operation
Primary Outcome Measure Information:
Title
Postoperative urinary complications
Description
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
Time Frame
From the time of surgery to post-operative Day 14.
Secondary Outcome Measure Information:
Title
Length of Hospital Stay
Description
Comparing the total length of hospital stay between the catheterized and non-catheterized arms
Time Frame
During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Title
Rate of Post-operative Hypotension
Description
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
Time Frame
During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Title
Total IV fluid administration
Description
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
Time Frame
First 48 hours of the perioperative period
Title
Validity of the bladder scanner tool relative to actual urine output
Description
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
Time Frame
During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Title
Rate of peri-operative pulmonary complications
Description
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
Time Frame
During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Title
Rate of peri-operative cardiac complications
Description
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
Time Frame
During patient hospital stay (Estimated to be between post-operative day 0 and day 7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Agzarian, MD, MPH, FRCSC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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McMaster Catheterization for Thoracoscopic Surgery Study

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