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

March 16, 2026 updated by: Elna A. Dalsgaard, Copenhagen University Hospital at Herlev

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERAS 3.0 group
Post-surgery support at discharge and at home
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.
No Intervention: Standard care group
Standard care, which is no support after discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative recovery
Time Frame: 10-14 days after surgery
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.
10-14 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health realted Quality of Life (HrQoL)
Time Frame: 12, 30 and 90 days after surgery
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.
12, 30 and 90 days after surgery
Postoperative recovery
Time Frame: 30 and 90 days after surgery
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.
30 and 90 days after surgery
Activities of daily living
Time Frame: 12, 30 and 90 days after surgery
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.
12, 30 and 90 days after surgery
Energy- and protein intake
Time Frame: 12, 30 and 90 days after surgery
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.
12, 30 and 90 days after surgery
Appetite
Time Frame: 12, 30 and 90 days after surgery
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.
12, 30 and 90 days after surgery
Weight
Time Frame: 12, 30 and 90 days after surgery
12, 30 and 90 days after surgery
Physical function and muscle strenght
Time Frame: 12, 30 and 90 days after surgery
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.
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

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.
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
Readmission rate is defined as any unplanned hospitalisation within 30 days after discharge from hospital.
within 30 days after discharge
Postoperative complications
Time Frame: within 30 and 90 days after discharge
The occurrence of post-operative complications, including infections requiring treatment within 30 and 90 days will be registered numerically.
within 30 and 90 days after discharge
Number of reoperations
Time Frame: within 1 and 6 months after discharge
The occurence of reoperations will be registered
within 1 and 6 months after discharge
Total length of hospital stay
Time Frame: within 6 months after discharge
within 6 months after discharge
Days alive and out of the hospital
Time Frame: within 30 and 90 days after discharge
within 30 and 90 days after discharge
Mortality
Time Frame: Within 1, 3, 6, and 12 months after primary surgery
Within 1, 3, 6, and 12 months after primary surgery
Muscle mass by CT
Time Frame: at baseline, after one and three years
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.
at baseline, after one and three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Collaborators

Danish Cancer Society

Investigators

  • Study Director: Jacob Rosenberg, Professor, dr. med., Center of Perioperative Optimisation, Copenhagen University Hospital at Herlev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 20, 2029

Study Registration Dates

First Submitted

January 19, 2025

First Submitted That Met QC Criteria

January 26, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24078496

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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