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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Care 4 Today ® (Johnson and Johnson) mobile app | Experimental | Patients will undergo standard perioperative management. Additionally, patients will use the Care 4 Today ® (Johnson and Johnson) mobile app for remote monitoring from the preoperative assessment day to 30 days after surgery. The Care 4 Today Care ® (Johnson and Johnson) mobile app will include daily reminds for preoperative recommendations adherence (water intake, medications adherence, mobilization, smoking quit...) and postoperative monitoring of symptoms (fever, pain, and mood deflections). |
|
| Standard perioperative management | No Intervention | The historic cohort include patients who underwent standard perioperative management from March 2020 to April 2023. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Unplanned hospital readmissions | Rate difference of unplanned hospital readmissions between the experimental group and historical cohort of comparison. | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annalisa Maroli, PhD | Contact | 02 8224 7776 | 0039 | colorapp@humanitas.it |
| Stefano De Zanet, MS | Contact | 02 8224 4623 | 0039 | colorapp@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Caterina Foppa, MD, PhD | Humanitas Research Hospital IRCCS, Rozzano-Milan | Principal Investigator |
| Spinelli Antonino, MD, PhD | Humanitas Research Hospital IRCCS, Rozzano-Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Humanitas Research Hospital | Recruiting | Rozzano | MI | 20089 | Italy |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Single-center, prospective, interventional case-series study with a historical cohort of comparison
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| 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 |
| 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 |
| Healthcare costs | Compare the healthcare resources utilization between the experimental group and the historical cohort of comparison. | 30 days after surgery |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |