Prehabilitation augmented Enhanced Recovery After Surgery in patients undergoing elective surgery for colorectal carcinoma: a randomized control trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 1)To compare the length of hospital stay, postoperative complications, and readmission
研究概览
简要总结
Background & Purpose of the Trial:
Patients undergoing surgery for colorectal cancer often face physical weakness, poor nutrition, and emotional stress, which can delay recovery. While Enhanced Recovery After Surgery (ERAS) protocols help improve outcomes after surgery, recent research suggests that helping patients get stronger before surgery—through exercise, better nutrition, and psychological support—may further improve results.
This study aims to find out whether adding a structured prehabilitation program before surgery leads to better fitness, mental health, and faster recovery in patients with colorectal cancer undergoing planned surgery.
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 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged 18-90 years 2.Both gender 3.Biopsy proven colorectal carcinoma requiring surgical resection 4.Able to provide informed consent 5.ASA 1 or 2 patients.
排除标准
- •1.Age less than 18yrs or more than 90yrs 2.Inability to comprehend or follow PERAS protocol 3.Patients not providing valid informed consent 4.Pregnant patients 5.Patients with psychiatric disorders 6.Patients presenting to emergency with obstruction or perforation in colorectal carcinomas.
结局指标
主要结局
1)To compare the length of hospital stay, postoperative complications, and readmission
时间窗: Primary outcomes pertaining to this study specifically includes those which are used to determine the effects of intervention i,e, prehabilitation.Measures including borg scale,6MWT,hand grip test,improvement in pulmonary function test,duke activity index,change in BMI,PHQ9,GAD7 score etc will be assessed, | 1.)At baseline, | 2.)At 4 weeks, | 3.)At 8 weeks, from the point of diagnosis/start of prehabilitative intervention.
rates between patients managed with Prehabilitation augumented ERAS and those receiving
时间窗: Primary outcomes pertaining to this study specifically includes those which are used to determine the effects of intervention i,e, prehabilitation.Measures including borg scale,6MWT,hand grip test,improvement in pulmonary function test,duke activity index,change in BMI,PHQ9,GAD7 score etc will be assessed, | 1.)At baseline, | 2.)At 4 weeks, | 3.)At 8 weeks, from the point of diagnosis/start of prehabilitative intervention.
traditional ERAS care.
时间窗: Primary outcomes pertaining to this study specifically includes those which are used to determine the effects of intervention i,e, prehabilitation.Measures including borg scale,6MWT,hand grip test,improvement in pulmonary function test,duke activity index,change in BMI,PHQ9,GAD7 score etc will be assessed, | 1.)At baseline, | 2.)At 4 weeks, | 3.)At 8 weeks, from the point of diagnosis/start of prehabilitative intervention.
2)To assess patient-reported outcomes, such as pain scores, bowel function recovery,
时间窗: Primary outcomes pertaining to this study specifically includes those which are used to determine the effects of intervention i,e, prehabilitation.Measures including borg scale,6MWT,hand grip test,improvement in pulmonary function test,duke activity index,change in BMI,PHQ9,GAD7 score etc will be assessed, | 1.)At baseline, | 2.)At 4 weeks, | 3.)At 8 weeks, from the point of diagnosis/start of prehabilitative intervention.
quality of life and emotional well being in the two groups.
时间窗: Primary outcomes pertaining to this study specifically includes those which are used to determine the effects of intervention i,e, prehabilitation.Measures including borg scale,6MWT,hand grip test,improvement in pulmonary function test,duke activity index,change in BMI,PHQ9,GAD7 score etc will be assessed, | 1.)At baseline, | 2.)At 4 weeks, | 3.)At 8 weeks, from the point of diagnosis/start of prehabilitative intervention.
3)To evaluate the cost-effectiveness of the Prehabilitation augumented ERAS protocol in
时间窗: Primary outcomes pertaining to this study specifically includes those which are used to determine the effects of intervention i,e, prehabilitation.Measures including borg scale,6MWT,hand grip test,improvement in pulmonary function test,duke activity index,change in BMI,PHQ9,GAD7 score etc will be assessed, | 1.)At baseline, | 2.)At 4 weeks, | 3.)At 8 weeks, from the point of diagnosis/start of prehabilitative intervention.
comparison to traditional ERAS pathways
时间窗: Primary outcomes pertaining to this study specifically includes those which are used to determine the effects of intervention i,e, prehabilitation.Measures including borg scale,6MWT,hand grip test,improvement in pulmonary function test,duke activity index,change in BMI,PHQ9,GAD7 score etc will be assessed, | 1.)At baseline, | 2.)At 4 weeks, | 3.)At 8 weeks, from the point of diagnosis/start of prehabilitative intervention.
次要结局
- 1)To assess readmission rates within 30 days post surgery(2)To assess response to adjuvant chemotherapy & related complications)
研究者
Dr Santhosh Kumar R
Postgraduate Institute of Medical Education and Research,Chandigarh