McMaster Catheterization for Thoracoscopic Surgery Study

NCT ID: NCT02640326

Last Updated: 2018-12-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2018-12-01

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.

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

No Foley Urinary Catheter

Intervention Type: OTHER

No Foley urinary catheter will be put in place during the operation

Experimental Arm

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

Group Type: EXPERIMENTAL

Standard of care Foley urinary catheter insertion

Intervention Type: OTHER

A Foley urinary catheter will be put in place during the operation

Interventions

No Foley Urinary Catheter

No Foley urinary catheter will be put in place during the operation

Intervention Type: OTHER

Standard of care Foley urinary catheter insertion

A Foley urinary catheter will be put in place during the operation

Intervention Type: OTHER

Other Intervention Names

Experimental Comparator; Active Comparator

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Agzarian, MD, MPH, FRCSC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

SJHH_UCATh

Identifier Type: -

Identifier Source: org_study_id