An Electronic Remote Application to Improve the Postoperative Outcomes in Colorectal Cancer Patients: Single-center, Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Unplanned hospital readmissions
研究概览
简要总结
The unplanned readmission rate after colorectal cancer surgery is still high, despite the implementation of enhanced recovery programs. The use of a mobile-based application for perioperative remote monitoring may improve the postoperative outcomes and reduce the unplanned postoperative readmissions.
详细描述
Despite the implementation of enhanced recovery programs, the rate of unplanned readmissions remains high after colorectal cancer surgery. These readmissions are often preventable with a better postoperative management. Increasing studies have demonstrated the feasibility and efficacy of perioperative remote monitoring mobile applications in improving the postoperative outcomes but are often limited to one restricted outcome. This project aims to evaluate the effect of the Care 4 Today® (Johnson & Johnson) perioperative mobile app on the postoperative outcomes of colorectal cancer patients, with a focus on unplanned readmissions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 aged more than 18 years old.
- •Patients scheduled for elective curative colorectal resection, including right (or extended) colectomy, left colectomy, rectal resection (with or without ileostomy), total colectomy, recanalization, or multiple colon resection.
- •Patients willing to comply with the study procedures.
- •Proficient understanding of the Italian language
排除标准
- •Any condition that, in the opinion of the investigator, may interfere with the study procedures.
- •Patients scheduled for palliative surgery.
- •Patients with a planned elective intervention requiring urgent or emergent surgery will be withdrawn from the study.
- •Pregnant or breastfeeding women.
- •Inability to comply with the study procedures.
研究组 & 干预措施
Care 4 Today ® (Johnson and Johnson) mobile app
Patients will undergo standard perioperative management. Additionally, patients will use the Care 4 Today ® (Johnson and Johnson) mobile app for remote monitoring from the preoperative assessment day to 30 days after surgery. The Care 4 Today Care ® (Johnson and Johnson) mobile app will include daily reminds for preoperative recommendations adherence (water intake, medications adherence, mobilization, smoking quit...) and postoperative monitoring of symptoms (fever, pain, and mood deflections).
干预措施: Care 4 Today ® (Johnson and Johnson) mobile app (Device)
Standard perioperative management
The historic cohort include patients who underwent standard perioperative management from March 2020 to April 2023.
结局指标
主要结局
Unplanned hospital readmissions
时间窗: 30 days after surgery
Rate difference of unplanned hospital readmissions between the experimental group and historical cohort of comparison.
次要结局
- Severity of postoperative complications(30 days after surgery)
- Length of hospital stay(From the day of surgery to the day of discharge)
- Time from symptoms onset to diagnosis(30 days after surgery)
- Healthcare costs(30 days after surgery)