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Recruiting NCT06302751

A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer

No phase Interventional Colorectal Cancer Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Care 4 Today ® (Johnson and Johnson) mobile app.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Unplanned hospital readmissions [Time frame: 30 days after surgery]
Secondary outcome measures (4)
  • Severity of postoperative complications [Time frame: 30 days after surgery]
  • Length of hospital stay [Time frame: From the day of surgery to the day of discharge]
  • Time from symptoms onset to diagnosis [Time frame: 30 days after surgery]
  • Healthcare costs [Time frame: 30 days after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Italy · 1 center
  • IRCCS Humanitas Research Hospital — Rozzano

Identifiers

NCT: NCT06302751 · 3647

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗