Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ERAS 3.0 (Enhanced Recovery After Surgery).
- Who it may be relevant to
- Registry conditions: Colon Cancer, Frailty. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other ERAS 3.0 (Enhanced Recovery After Surgery)
Nutritional support at discharge and home visits which include comprehensive geriatric assessment, nutritional guidance by dietitian, and instructions on exercise and physical activity.
Primary outcome measures
- Postoperative recovery [Time frame: 10-14 days after surgery]
Secondary outcome measures (12)
- Health realted Quality of Life (HrQoL) [Time frame: 12, 30 and 90 days after surgery]
- Postoperative recovery [Time frame: 30 and 90 days after surgery]
- Activities of daily living [Time frame: 12, 30 and 90 days after surgery]
- Energy- and protein intake [Time frame: 12, 30 and 90 days after surgery]
- Appetite [Time frame: 12, 30 and 90 days after surgery]
- Weight [Time frame: 12, 30 and 90 days after surgery]
- Physical function and muscle strenght [Time frame: 12, 30 and 90 days after surgery]
- Muscle mass by BIA [Time frame: 12, 30 and 90 days after surgery as well as 1 (CT) and 3 (CT) years after surgery]
- Rate of readmission [Time frame: within 30 days after discharge]
- Postoperative complications [Time frame: within 30 and 90 days after discharge]
- Number of reoperations [Time frame: within 1 and 6 months after discharge]
- Total length of hospital stay [Time frame: within 6 months after discharge]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Denmark · 2 centers
- University Hospital Herlev — Herlev
- University Hospital Herlev — Herlev
Publications
- Munk T, Svendsen JA, Knudsen AW, Ostergaard TB, Thomsen T, Olesen SS, Rasmussen HH, Beck AM. A multimodal nutritional intervention after discharge improves quality of life and physical function in older patients - a randomized controlled trial. Clin Nutr. 2021 Nov;40(11):5500-5510. doi: 10.1016/j.clnu.2021.09.029. Epub 2021 Sep 24. PMID 34656032
- Dolin TG, Mikkelsen M, Jakobsen HL, Nordentoft T, Pedersen TS, Vinther A, Zerahn B, Vistisen KK, Suetta C, Nielsen D, Johansen JS, Lund CM. Geriatric assessment and intervention in older vulnerable patients undergoing surgery for colorectal cancer: a protocol for a randomised controlled trial (GEPOC trial). BMC Geriatr. 2021 Jan 30;21(1):88. doi: 10.1186/s12877-021-02045-9. PMID 33516195
Identifiers
NCT: NCT06802991 · H-24078496