An interventional study of ERAS 3.0 (Enhanced Recovery After Surgery) in Colon Cancer and Frailty, sponsored by Copenhagen University Hospital at Herlev. Recruiting at 2 sites in Denmark. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Copenhagen University Hospital at Herlev · Not applicable, Interventional, and Supportive care
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.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Copenhagen University Hospital at Herlev is the lead sponsor of 77 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 21, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Post-surgery support at discharge and at home
Other: ERAS 3.0 (Enhanced Recovery After Surgery)
Standard care, which is no support after discharge
Nutritional support at discharge and home visits which include comprehensive geriatric assessment, nutritional guidance by dietitian, and instructions on exercise and physical activity.
Postoperative recovery
Postoperative recovery is measured as a change in the Quality of Recovery-15 questionnaire. Through 15 questions, the time spent in common postoperative conditions during the last 24 hours is estimated. Each question has a scale from 0 to 10, resulting in a maximum total score of 150.
Time frame: 10-14 days after surgery
Health realted Quality of Life (HrQoL)
HrQoL will be measured using the EQ-5D-5L questionnaire. The EQ-5D-5L questionnaire comprises five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has five response categories, ranging from having no problems to being unable to perform the activity. The responses are converted into a utility index value, reflecting health status compared to the reference of the general population (norm data). A visual analogue scale (VAS) is also included, where health is rated on a scale from 0 (worst health you can imagine) to 100 (best health you can imagine). Permission will be sought to use the tool.
Time frame: 12, 30 and 90 days after surgery
Postoperative recovery
Postoperative recovery is measured as a change in the Quality of Recovery-15 questionnaire. Through 15 questions, the time spent in common postoperative conditions during the last 24 hours is estimated. Each question has a scale from 0 to 10, resulting in a maximum total score of 150.
Time frame: 30 and 90 days after surgery
Activities of daily living
Activities in daily living are assessed using the Functional Recovery Score (FRS) to evaluate functional recovery after surgery. The eleven-item questionnaire comprises three main components: basic activities of daily living (BADL), assessed by four items; instrumental activities of daily living (IADL), assessed by six items; and mobility, assessed by one item. BADL accounts for 44 percent of the score, IADL for 23 percent, and mobility for 33 percent. Complete independence results in a score of 100 percent.
Time frame: 12, 30 and 90 days after surgery
Energy- and protein intake
Energy and protein intake will be estimated using the 24-hour dietary recall interview method. The interviews will be conducted by the investigator working on the study. The foods and drinks will be entered into the software program Vitakost to calculate the intake of protein (g) and energy (kJ) and liquid (mL). The participant's body weight will be used to calculate the intake per kilogram of body weight. The cut-off for suspecting underreporting will be evaluated retrospectively on an individual basis, taking into account any illness, readmissions, loss of body weight, activity level etc.
Time frame: 12, 30 and 90 days after surgery
Appetite
Appetite will be assessed using the Simplified Nutritional Appetite Questionnaire (SNAQ), which consists of four questions adressing appetite, taste, satiety, and meal frequency. Each question offers five possible answers, and participants select the category that best reflects their current situation. The total score ranges from 5 to 20.
Time frame: 12, 30 and 90 days after surgery
Weight
Time frame: 12, 30 and 90 days after surgery
Physical function and muscle strenght
Physical function and muscle strength will be assessed using the 30-second chair stand test (30s CST), which measures the number of times an individual can rise from and sit down in a standardized chair within 30 seconds. To accommodate participants' abilities, the chair stand test will be modified according to three versions as needed.
Time frame: 12, 30 and 90 days after surgery
Muscle mass by BIA
Total and appendicular muscle mass (kg and percent) will be measured by bioelectrical impedance analysis (BIA). This method involves passing a low-level electrical current through the body to measure electrical impedance, or resistance, encountered by the current as it flows through different tissues. Tissues rich in electrolyte-containing water, such as skeletal muscle, have lower resistance and thus higher conductivity. Conductivity is directly proportional to total body water. Lean muscle mass is derived from the conductivity measurement, and fat mass (in kilograms and percentage) is subsequently calculated by subtracting lean muscle mass from total body weight. Body weight and height are entered manually to aid in calculations.
Time frame: 12, 30 and 90 days after surgery as well as 1 (CT) and 3 (CT) years after surgery
Rate of readmission
Readmission rate is defined as any unplanned hospitalisation within 30 days after discharge from hospital.
Time frame: within 30 days after discharge
Postoperative complications
The occurrence of post-operative complications, including infections requiring treatment within 30 and 90 days will be registered numerically.
Time frame: within 30 and 90 days after discharge
Number of reoperations
The occurence of reoperations will be registered
Time frame: within 1 and 6 months after discharge
Total length of hospital stay
Time frame: within 6 months after discharge
Days alive and out of the hospital
Time frame: within 30 and 90 days after discharge
Mortality
Time frame: Within 1, 3, 6, and 12 months after primary surgery
Muscle mass by CT
Muscle mass by will be measured by computed tomography (CT) scan. All CT scans are part of routine care concerning the cancer disease and are therefore not research-related add-ons to routine care.
Time frame: at baseline, after one and three years
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Copenhagen University Hospital at Herlev