McMaster Catheterization for Thoracoscopic Surgery Study

Non-Small Cell Lung Cancer Clinical Trial

— UCATh  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02640326
• Other study ID #: SJHH_UCATh
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Lung Cancer
• Non-Small Cell Lung Cancer
• Urinary Retention
• Urinary Tract Infections

Intervention

Other:
• No Foley Urinary Catheter
No Foley urinary catheter will be put in place during the operation
• Standard of care Foley urinary catheter insertion
A Foley urinary catheter will be put in place during the operation

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of Hospital Stay	Comparing the total length of hospital stay between the catheterized and non-catheterized arms	During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Secondary	Rate of Post-operative Hypotension	Post-operative hypotension will be defined as systolic blood pressure less than 80 mmHg for > 6 hours requiring active fluid resuscitation. The comparison will be made of rate of occurrence between the catheterized and non-catheterized arms to account for varied volumes of fluid intake that may confound observations	During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Secondary	Total IV fluid administration	The comparison will be made of rate of occurrence between the catheterized and non-catheterized arms to account for varied volumes of fluid intake that may confound observations	First 48 hours of the perioperative period
Secondary	Validity of the bladder scanner tool relative to actual urine output	In patients who underwent a bladder scan for suspected urinary retention (Failure to pass urine within 8 +/-2 hours of de-catheterization or after surgery), it is necessary to measure how accurate the bladder scan procedure is relative to the actual amount of urine in the bladder. The bladder scanner will generate an estimate of the amount of urine in the bladder, but the accuracy is not known. The volume of urine collected from the catheter by nursing staff or as measured from a urine collection hat and compared to the reading from the bladder scanner	During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Secondary	Rate of peri-operative pulmonary complications	Pulmonary complications defined as Grade II or greater according to the Ottawa Thoracic Morbidity and Mortality (TM&M) scale (requiring treatment). The comparison will be made of rate of complication occurrence between the catheterized and non-catheterized arms	During patient hospital stay (Estimated to be between post-operative day 0 and day 7)
Secondary	Rate of peri-operative cardiac complications	Cardiac complications defined as Grade I or greater according to the Ottawa Thoracic Morbidity and Mortality (TM&M) scale (no treatment required). The comparison will be made of rate of complication occurrence between the catheterized and non-catheterized arms	During patient hospital stay (Estimated to be between post-operative day 0 and day 7)