NCT03592316已完成不适用
Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Hospital length of stay
研究概览
简要总结
The LEAP protocol is a prospective cohort study of dysvascular patients designed to determine whether implementation of a multi-disciplinary lower extremity amputation protocol in the peri-operative period can shorten post-operative length of stay in patients undergoing trans-tibial or trans-femoral amputations. A consecutive sample of patients diagnosed with peripheral vascular disease and/or diabetes requiring major lower extremity amputation will be enrolled in the study and compared to retrospective controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients >18 years of age diagnosed with peripheral vascular disease and/or diabetes mellitus
- •Patients undergoing trans-tibial or trans-femoral amputations
排除标准
- •Patients undergoing amputation for trauma, malignancy, or necrotizing fasciitis with no dysvascular diagnosis
- •Patients who have previously undergone an amputation
- •Patients who were unable to function independently prior to admission
- •Patients admitted to the ICU prior to surgery
- •Attending surgeon does not approve of the patient being enrolled
- •Prisoners
- •Pregnant women
结局指标
主要结局
Hospital length of stay
时间窗: Through hospital discharge, approximately 3 days after surgery
The total hospital length of stay for the lower extremity amputation admission
次要结局
- In-hospital morbidity(Through hospital discharge, approximately 3 days after surgery)
- Return to functional independence(Up to 6 months after surgery)
- Mortality(Up to 6 months after surgery)
- Major adverse limb event(Up to 6 months after surgery)
研究者
研究点 (2)
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