Impact of Enhanced Prehabilitation on Postoperative Outcomes in Major Oncological Surgeries: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Postoperative complications according to Clavien-Dindo Classification
研究概览
简要总结
Randomized controlled trial in patients undergoing major oncological surgery comparing standard prehabilitation with enhanced prehabilitation. Standard care includes nutrition supplementation and incentive spirometry. Enhanced program adds resistance training aerobic exercises cycling meditation and handgrip strengthening. The aim is to assess whether enhanced prehabilitation reduces postoperative complications and improves recovery. The study will also look at hospital length of stay functional recovery and quality of life. This is a single center study conducted at AIIMS Mangalagiri with equal randomization into two groups. Findings may guide the adoption of cost effective prehabilitation protocols in cancer surgery preparation in India.
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
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (greater than 18 years) undergoing primary Head and neck, Thoracic, Abdominal and Pelvic oncologic surgery.
- •Histopathologically confirmed malignancies requiring surgical intervention.
排除标准
- •Patients undergoing palliative surgery or non-curative resections.
- •Patients with pre-existing bone diseases, and neuromuscular disorders affecting muscle function., heart dysfunction, liver dysfunction, renal dysfunction.
- •Severe renal or hepatic dysfunction affecting metabolism and muscle mass.
- •Patients who decline consent.
- •Patients with recurrent and metastatic disease.
- •Patients with age greater than 75 years.
结局指标
主要结局
Postoperative complications according to Clavien-Dindo Classification
时间窗: 30 days post operative period
次要结局
- ICU and hospital stays
- Nutritional and muscle status(30 days postoperative period)
研究者
Dr Gunasekhar Vamsi Krishna
AIIMS Mangalagiri