A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer
- Conditions
- Colorectal CancerSurgery
- Interventions
- Device: Care 4 Today ® (Johnson and Johnson) mobile app
- Registration Number
- NCT06302751
- Lead Sponsor
- Istituto Clinico Humanitas
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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
- 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- Patients with a planned elective intervention requiring urgent or emergent surgery will be withdrawn from the study.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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Care 4 Today ® (Johnson and Johnson) mobile app 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).
- Primary Outcome Measures
Name Time Method Unplanned hospital readmissions 30 days after surgery Rate difference of unplanned hospital readmissions between the experimental group and historical cohort of comparison.
- Secondary Outcome Measures
Name Time Method Severity of postoperative complications 30 days after surgery Compare the severity of postoperative complications- classified according to the Clavien-Dindo scale (ranging from 0 \[no postoperative complications\] to 5 \[postoperative complications leading to death\]- between the experimental group and historical cohort of comparison.
Length of hospital stay From the day of surgery to the day of discharge Compare the median length of hospital stay (calculated in days from the day of surgery to the day of discharge) between the experimental group and the historical cohort of comparison.
Time from symptoms onset to diagnosis 30 days after surgery Compare the time (in hours) from symptoms onset to diagnosis of postoperative complications occurring in the experimental group and historical cohort of comparison.
Healthcare costs 30 days after surgery Compare the healthcare resources utilization between the experimental group and the historical cohort of comparison.
Trial Locations
- Locations (1)
IRCCS Humanitas Research Hospital
🇮🇹Rozzano, MI, Italy