Optimized ERAS 3.0 home recovery program for older adults after colon cancer surgery
Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)
NA · Copenhagen University Hospital at Herlev · NCT06802991
This trial will test whether a home-based ERAS 3.0 program of geriatric assessment, diet counseling, and guided physical activity helps frail patients aged 65 and older recover better after colon cancer surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Copenhagen University Hospital at Herlev (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Herlev and 1 other locations) |
| Trial ID | NCT06802991 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares an extended post-discharge ERAS 3.0 program to standard care in elderly, frail patients after elective minimally invasive colon cancer resection. The ERAS 3.0 intervention includes a comprehensive geriatric assessment, dietary counseling from a dietitian, and home-based instructions for training and physical activity delivered after hospital discharge. Data are collected at the hospital, at a 12-day outpatient visit, and at one and three months post-discharge with home visits for follow-up. Key eligibility includes age ≥65, Clinical Frailty Scale 4–7, NRS-2002 >3, no planned stoma, and discharge to the patient’s own home.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 or older who are frail (CFS 4–7), nutritionally at risk (NRS-2002 >3), undergoing elective minimally invasive colon resection with no planned stoma and who will be discharged to their own home.
Not a fit: Patients who require stoma creation or conversion to open surgery, develop major postoperative complications, are discharged to 24-hour rehabilitation, need tube feeding, or cannot adhere to home visits or provide consent are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could speed functional recovery, improve nutrition and independence, and reduce postoperative complications and readmissions.
How similar studies have performed: Conventional ERAS protocols have improved short-term outcomes after colorectal surgery, but adding structured home-based geriatric and nutritional support is a relatively novel approach with limited randomized evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Herlev and 1 other locations
- University Hospital Herlev — Herlev, Denmark (NOT_YET_RECRUITING)
- University Hospital Herlev — Herlev, Denmark (RECRUITING)
Study contacts
- Study coordinator: Elna A. Dalsgaard, ph.d. student
- Email: elna.adalsteinsdottir.dalsgaard@regionh.dk
- Phone: +45 42402296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colon Cancer, Frailty, ERAS 3.0, colon cancer surgery, comprehensive geriatric assessment