NCT06802991 Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)
| NCT ID | NCT06802991 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Copenhagen University Hospital at Herlev |
| Condition | Colon Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-04-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Jacob Rosenberg, Professor, dr. med.
STUDY DIRECTOR
Center of Perioperative Optimisation, Copenhagen University Hospital at Herlev
Frequently Asked Questions
Who can join the NCT06802991 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Colon Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06802991 currently recruiting?
Yes, NCT06802991 is actively recruiting participants. Contact the research team at elna.adalsteinsdottir.dalsgaard@regionh.dk for enrollment information.
Where is the NCT06802991 trial being conducted?
This trial is being conducted at Herlev, Denmark, Herlev, Denmark.
Who is sponsoring the NCT06802991 clinical trial?
NCT06802991 is sponsored by Copenhagen University Hospital at Herlev. The principal investigator is Jacob Rosenberg, Professor, dr. med. at Center of Perioperative Optimisation, Copenhagen University Hospital at Herlev. The trial plans to enroll 60 participants.
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