Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)
Recruiting · NCT06802991 · Interventional (participants receive a specific treatment) · Lead sponsor: Copenhagen University Hospital at Herlev
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of the study is to investigate whether an extended program (ERAS 3.0) initiated hospital discharge, can improve recovery in elderly, frail patients who have undergone surgery for colon cancer. The study is a randomised controlled trial with two groups: an intervention group receiving the ERAS 3.0 program and a control group recieving standard care. The ERAS 3.0 program includes a comprehensive geriatric health assessment, dietary counseling from a dietitian, and instructions on training and physical activity. These activities will take place in the participant's homes after hospital discharge. Data will be collected at multiple time points: at the hospital, 12 days post-discharge (at the outpatient clinic), and at 1 and 3 months post discharge in the participants' homes.
Who can take part
Inclusion criteria
- Age 65+
- Clinical Frailty Scale preoperative score 4-7
- Nutritional Risk Screening tool (NRS 2002) \> 3
- Elective colonic resection
- No stoma planned
- Minimally invasive surgical approach (laparoscopic or robotic)
- Patients discharged to own home
- Informed consent to participate
Exclusion criteria
- Stoma creation during index surgery
- Conversion to laparotomy
- Major complications following surgery (Clavien-Dindo \>3a)
- Participation in other randomised trials in conflict with the protocol and end- points of the ERAS 3.0 project
- Discharged with tube feeding and parenteral nutrition (partially or completely)
- Known food allergies to dairy or any other ingredient contained in the nutrition package
- Incapable of providing informed consent
- Discharge to 24-hour municipal rehabilitation facility
- All conditions including psychological, geographical, and social factors that could hinder adherence to the trial protocol
- Neoadjuvant radio- or chemotherapy
Where it is running
2 locations listed.
- University Hospital Herlev - Herlev, Denmark
- University Hospital Herlev - Herlev, Denmark