McMaster Catheterization for Thoracoscopic Surgery 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)

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 such a study is feasible and will test the suitability of new patient quality of life tools. Secondarily, the study will look to see if there is a difference in post operative urinary complications between the groups. Should this study prove to be feasible, the information learned will be used to determine the sample size and requirements for a fully powered trial, in order to definitively determine whether a Foley urine catheter is a necessary procedure in the course of a minimally invasive lung resection.

Trial Description

Primary Outcome:

  • Composite Primary Feasibility Outcome: Monthly rate of patient accrual
  • Composite Primary Feasibility Outcome: Ratio of recruitment rates to randomization rates
  • Composite Primary Feasibility Outcome: Monthly rate of patient withdrawal from assigned intervention
  • Composite Primary Feasibility Outcome: Rate of surgeon adherence to the study protocol
Secondary Outcome:
  • Length of Hospital Stay
  • Rate of Post-operative Hypotension
  • Total IV fluid administration
  • Validity of the bladder scanner tool relative to actual urine output
  • Determine the level of patient quality of life relating to urinary catheterization
  • Rate of expected peri-operative adverse events related to catheterisation
  • Rate of peri-operative pulmonary complications
  • Rate of peri-operative cardiac complications
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. Patients will complete pre/post-op questionnaires at baseline and at the first followup visit, and feasibility outcomes will be collected. The primary objective is to assess the feasibility of a full scaled trial.

View this trial on ClinicalTrials.gov

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Resources

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