A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer

Colorectal Cancer Clinical Trial

— RAISe-Care  

Official title:

An Electronic Remote Application to Improve the Postoperative Outcomes in Colorectal Cancer Patients: Single-center, Interventional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302751
• Other study ID #: 3647
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: August 31, 2026

Study information

• Verified date: March 2024
• Source: Istituto Clinico Humanitas
• Contact: Annalisa Maroli, PhD
• Phone: 02 8224 7776
• Email: colorapp[@]humanitas.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 31, 2026
• Est. primary completion date: February 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Surgery

Intervention

Device:
• Care 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.

Locations

Country	Name	City	State
Italy	IRCCS Humanitas Research Hospital	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unplanned hospital readmissions	Rate difference of unplanned hospital readmissions between the experimental group and historical cohort of comparison.	30 days after surgery
Secondary	Severity of postoperative complications	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.	30 days after surgery
Secondary	Length of hospital stay	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.	From the day of surgery to the day of discharge
Secondary	Time from symptoms onset to diagnosis	Compare the time (in hours) from symptoms onset to diagnosis of postoperative complications occurring in the experimental group and historical cohort of comparison.	30 days after surgery
Secondary	Healthcare costs	Compare the healthcare resources utilization between the experimental group and the historical cohort of comparison.	30 days after surgery