Early Versus Delayed Urinary Catheter Removal After Minimally Invasive Lumbar Spine Surgery: A Randomized-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Ambulation
研究概览
简要总结
The study aims to compare between early versus delayed urinary catheter removal the impact on time to ambulation (in minutes) after minimally invasive lumbar spine surgery
详细描述
Early ambulation enables rapid removal of drainage tubes and canisters and decreases length of hospitalization. Previous article showed that a 1-day shorter in hospitalization led to an approximately US$ 2000 reduction in total patient costs. Another study examining patients after total knee arthroplasty found that an early discharge group, a decrease in length of stay in 22h resulted in financial savings of approximately US$ 600 per case.
Another author found that early ambulation was associated with 19% lower 90-day readmission rate. Moreover, early ambulation contributed to 50.6% lower probability of developing at least one complication than regular ambulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patients aged 18 years and older
- •Minimally invasive one- or two-level lumbar fusion procedures
排除标准
- •Patients that cannot give consent
- •Patients with lower extremity amputation(s);
- •Non-minimally invasive surgeries
- •Patients with pre-existing bladder/kidney or urinary tract dysfunction
- •Patients with spinal cord injuries
- •Patients with known lower extremity weakness and impaired mobility.
结局指标
主要结局
Ambulation
时间窗: After the surgery, postoperative day 1
Time in minutes to ambulation
次要结局
- Home discharge(Average postoperative day 1-3)
- Pain medication(Hospitalization period: postoperative day 1, 2, 3)
- Urinary tract infection(From date of the surgery until the date of first documented event, whichever came first, assessed up to 1 month after the surgery)
- Physical therapy progression(Hospitalization period: postoperative day 1, 2, 3)
- Hospital length of stay(1 to 3 days)
- Facility discharge(Average postoperative day 1-3)
- Urinary catheter reinsertion(From date of the surgery until the date of first documented event, whichever came first, assessed up to discharge (1 to 3 days) after the surgery)
研究者
Brandon Carlson, MD, MPH
Principal Investigator
University of Kansas Medical Center