The Effect of Prehabilitation on Surgical Complications Following Colon Surgery - a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Region Skane
- 入组人数
- 160
- 主要终点
- Complications
研究概览
简要总结
The study aims to find out if complications after surgery for large bowel (colon) cancer can be reduced or avoided in the most frail and elderly by letting them go through an exercise- and diet regime prior to the surgical procedure.
详细描述
All patients with colon cancer who are intended for curative surgery without neoadjuvant chemotherapy who are >=60 years old will be screened with an ergospirometry. The ones that have a ventilate anaerobic threshold (VAT) of less than 11 mg/ml/kg will be included in the study as they are considered extra frail and have a previously proven high risk for complications. These patients will be randomized to standard care or an intervention of prehabilitation consisting of immunonutrition (protein supplement, multivitamin supplement, Selene etc) and an exercise regimen with 4x1 hours per week of cycling on an ergometer. The exercise regimen will be performed in a group of patients and will be led by a physical therapist to ensure compliance. The resistance of the ergometer will be standardized according to the patient's VAT.
The primary outcome measures will be number of and severity of postoperative complications. Secondary outcome measures include quality of life during prehabilitation with repeated measurements during 5 years after surgery, disease-free survival and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 years of older
- •Colon cancer diagnosis (macroscopic, microscopic or x-ray diagnosed)
- •Ventilatory Anaerobic Threshold <11mg/ml/kg
- •Planned open or laparoscopic colectomy due to colon cancer
排除标准
- •Lower extremity amputee
- •Disease requiring radio- and/or chemotherapy prior to surgery/palliative disease
- •Distal metastases (Locoregional lymph nodes are OK)
结局指标
主要结局
Complications
时间窗: Assessed at postoperative day 5.
Number of complication(s) according to POMS
次要结局
- Quality of life with SF-36(At point in time when patient is informed of the cancer, after prehabilitation (just before surgery), 30 days, 2, 3 and 6 months, 1, 3 and 5 years after surgery.)
- Disease-free survival(30 and 90 days after surgery, 1, 3 and 5 years after surgery.)
- Overall survival(30 and 90 days after surgery, 1, 3 and 5 years after surgery.)