Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)

Copenhagen University Hospital at Herlev

Status: Enrolling

Conditions: Colon Cancer; Frailty

Treatments: Other: ERAS 3.0 (Enhanced Recovery After Surgery)

Study type: Interventional

Funder types: Other

Identifiers

NCT06802991

H-24078496

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

ERAS 3.0 group

Experimental group

Description:

Post-surgery support at discharge and at home

Treatment:

Other: ERAS 3.0 (Enhanced Recovery After Surgery)

Standard care group

No Intervention group

Description:

Standard care, which is no support after discharge