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)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Postoperative urinary complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Postoperative urinary complications
时间窗: From the time of surgery to post-operative Day 14.
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
次要结局
- Rate of peri-operative pulmonary complications(During patient hospital stay (Estimated to be between post-operative day 0 and day 7))
- 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 cardiac complications(During patient hospital stay (Estimated to be between post-operative day 0 and day 7))