Colorectal Cancer, Surgery
Conditions
Keywords
Colorectal cancer, Surgery, Mobile app, Unplanned readmissions
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.
Interventions
DEVICECare 4 Today ® (Johnson and Johnson) mobile app
Care 4 Today ® (Johnson and Johnson) mobile app will cover the perioperative period spanning through the preoperative assessment day (approximately -seven to -one from surgery) to 30 days after surgery and will monitor the adherence to preoperative and postoperative recommendations.
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single-center, prospective, interventional case-series study with a historical cohort of comparison
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Patients with a planned elective intervention requiring urgent or emergent surgery will be withdrawn from the study.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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned hospital readmissions | 30 days after surgery | Rate difference of unplanned hospital readmissions between the experimental group and historical cohort of comparison. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactAnnalisa Maroli, PhD
Backup ContactStefano De Zanet, MS
Outcome results
None listed