McMaster Catheterization for Thoracoscopic Surgery Study

NCT02640326 | Withdrawn

• 1 other identifier: SJHH_UCATh
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  From the time of surgery to post-operative Day 14.

Secondary Outcomes (6)

• Length of Hospital Stay

  During patient hospital stay (Estimated to be between post-operative day 0 and day 7)

• Rate of Post-operative Hypotension

  During patient hospital stay (Estimated to be between post-operative day 0 and day 7)

• Total IV fluid administration

  First 48 hours of the perioperative period

• Validity of the bladder scanner tool relative to actual urine output

  During patient hospital stay (Estimated to be between post-operative day 0 and day 7)

• Rate of peri-operative pulmonary complications

  During patient hospital stay (Estimated to be between post-operative day 0 and day 7)

Study Arms (2)

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.

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

Other: Standard of care Foley urinary catheter insertion

Interventions

No Foley Urinary Catheter OTHER

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

Also known as: Experimental Comparator

Active Comparator

Standard of care Foley urinary catheter insertion OTHER

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

Also known as: Active Comparator

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Urinary Retention; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections

Study Officials

• John Agzarian, MD, MPH, FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 28, 2015
• Study Start: December 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)