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NCT Number: NCT06302751

A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Patients with a planned elective intervention requiring urgent or emergent surgery will be withdrawn from the study.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.

Treatment and study plan

Care 4 Today ® (Johnson and Johnson) mobile app

Device

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.

Primary outcomes

  1. Unplanned hospital readmissions

    Time frame: 30 days after surgery

    Rate difference of unplanned hospital readmissions between the experimental group and historical cohort of comparison.

Secondary outcomes

  1. Severity of postoperative complications

    Time frame: 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.

  2. Length of hospital stay

    Time frame: 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.

  3. Time from symptoms onset to diagnosis

    Time frame: 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.

  4. Healthcare costs

    Time frame: 30 days after surgery

    Compare the healthcare resources utilization between the experimental group and the historical cohort of comparison.

Study contacts

Contact information is provided by the study sponsor or research team.

Annalisa Maroli, PhD

CONTACT

[email protected]

02 8224 7776 ext. 0039

Stefano De Zanet, MS

CONTACT

[email protected]

02 8224 4623 ext. 0039

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Acronym: RAISe-Care

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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