Enhanced recovery pathway for lower limb amputations in peripheral arterial disease: randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Postoperative length of stay (PO-LOS)
研究概览
简要总结
This randomized control trial aims to evaluate the effect of an enhanced recovery pathway on patients undergoing major lower limb amputation due to peripheral arterial disease (PAD). The intervention group will receive a multidisciplinary LEAP protocol-based care that includes prehabilitation, perioperative physiotherapy, multimodal analgesia, early mobilisation, and prosthetic counselling. The control group will receive traditional postoperative care. The primary outcome is postoperative length of stay. Secondary outcomes include time to prosthesis application and time to independent ambulation. A total of 50 patients will be enrolled (25 in each group). The study will be conducted in the Department of General Surgery, PGIMER, Chandigarh from January 2025 to January 2026
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Age above 40 years Diagnosed peripheral arterial disease Clinical WiFi stage 5 with unsalvageable limb Ankle Brachial Index less than 0.9 or more than 1.2 (non-compressible arteries) Provided informed consent.
排除标准
- •Trauma and burn patients Non-ambulatory patients H/O contralateral amputation.
结局指标
主要结局
Postoperative length of stay (PO-LOS)
时间窗: 3 DAYS
次要结局
- Time to receipt of prosthesis(Measured from date of surgery to prosthesis application ( week 8))
- Time to independent ambulation(Measured from date of surgery to first documented independent ambulation (month 3))
研究者
AKANKSHA KUMARI
PGIMER, Chandigarh