Clinical trial NCT06302751: A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer
Official title: An Electronic Remote Application to Improve the Postoperative Outcomes in Colorectal Cancer Patients: Single-center, Interventional Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Surgery
Keywords: Colorectal cancer
Surgery
Mobile app
Unplanned readmissions
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, prospective, interventional case-series study with a historical cohort of comparison
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Unplanned hospital readmissions
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Severity of postoperative complications
timeFrame: 30 days after surgery
measure: Length of hospital stay
timeFrame: From the day of surgery to the day of discharge
measure: Time from symptoms onset to diagnosis
timeFrame: 30 days after surgery
measure: Healthcare costs
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Humanitas Research Hospital
state: MI
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Caterina Foppa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Spinelli Antonino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: