Non-Small Cell Lung CancerUCAThNCT02640326
McMaster Catheterization for Thoracoscopic Surgery Study
A study testing No Foley Urinary Catheter in people with Non-Small Cell Lung Cancer and Lung Neoplasms, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Lung Neoplasms, Metastatic Lung Cancer
- What is being tested?
- No Foley Urinary Catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer, Lung Neoplasms, Metastatic Lung Cancer, Urinary Retention, Urinary Tract Infections
- Being tested
- No Foley Urinary Catheter, Standard of care Foley urinary catheter insertion
- Keywords
- Urinary Catheterization, Randomized Controlled Trial, Thoracic Surgery, Video-Assisted, Quality Improvement, Evidence-Based Practice, Post-operative complications
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Urinary Retention, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Foley Urinary CatheterOther
Also called Experimental Comparator
No Foley urinary catheter will be put in place during the operation
Standard of care Foley urinary catheter insertionOther
Also called Active Comparator
A Foley urinary catheter will be put in place during the operation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Foley Urinary Catheter |
| Experimental Arm | Experimental | 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 Receives: Other: Standard of care Foley urinary catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the time of surgery to post-operative Day 14.
Secondary outcomes (6)
Length of Hospital Stay
Comparing the total length of hospital stay between the catheterized and non-catheterized arms
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study start1 Dec 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Why it stopped: Research question no longer useful/feasible due to shifts in standards of care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Agzarian, MD, MPH, FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640326
- Sponsor's protocol ID
- SJHH_UCATh
- Acronym
- UCATh
- Status last verified
- Dec 2018
- First submitted
- 22 Dec 2015
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02640326
- Acronym / sponsor ID
- UCATh / SJHH_UCATh
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research question no longer useful/feasible due to shifts in standards of care
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 28 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Other: No Foley Urinary CatheterThe 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. |
| Experimental Arm | Experimental | Other: Standard of care Foley urinary catheter insertionThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Foley Urinary CatheterAlso: Experimental ComparatorNo Foley urinary catheter will be put in place during the operation | Other | Active Comparator |
| Standard of care Foley urinary catheter insertionAlso: Active ComparatorA Foley urinary catheter will be put in place during the operation | Other | Experimental Arm |
Primary outcome
Postoperative urinary complications
Time frame: From the time of surgery to post-operative Day 14.
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
6 secondary outcomes
Length of Hospital Stay
Time frame: During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Rate of Post-operative Hypotension
Time frame: During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Total IV fluid administration
Time frame: First 48 hours of the perioperative period
Validity of the bladder scanner tool relative to actual urine output
Time frame: During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Rate of peri-operative pulmonary complications
Time frame: During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Rate of peri-operative cardiac complications
Time frame: During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Agzarian, MD, MPH, FRCSC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Foley Urinary Catheter in people with Non-Small Cell Lung Cancer and Lung Neoplasms, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative urinary complications (time frame: From the time of surgery to post-operative Day 14.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.