Clinical trial NCT02640326: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
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
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Postoperative urinary complications
timeFrame: From the time of surgery to post-operative Day 14.
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
measure: Rate of Post-operative Hypotension
timeFrame: During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
measure: Total IV fluid administration
timeFrame: First 48 hours of the perioperative period
measure: Validity of the bladder scanner tool relative to actual urine output
timeFrame: During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
measure: Rate of peri-operative pulmonary complications
timeFrame: During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
measure: Rate of peri-operative cardiac complications
timeFrame: During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: John Agzarian, MD, MPH, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: