Trials / Withdrawn
WithdrawnNCT02640326
McMaster Catheterization for Thoracoscopic Surgery Study
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)
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- McMaster University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Non-Small Cell Lung Cancer
- Lung Neoplasms
- Metastatic Lung Cancer
- Urinary Retention
- Urinary Tract Infections
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No Foley Urinary Catheter | No Foley urinary catheter will be put in place during the operation |
| OTHER | Standard of care Foley urinary catheter insertion | A Foley urinary catheter will be put in place during the operation |
Timeline
- Start date
- 2018-12-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2015-12-28
- Last updated
- 2018-12-21
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02640326. Inclusion in this directory is not an endorsement.