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Colon CancerNCT06802991

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

A study testing ERAS 3.0 (Enhanced Recovery After Surgery) in people with Colon Cancer and Frailty, run by Copenhagen University Hospital at Herlev at 2 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Colon Cancer, Frailty
What is being tested?
ERAS 3.0 (Enhanced Recovery After Surgery)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesDenmark
Study dates
1 Apr 2025to 20 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Clinical Frailty Scale preoperative score 4-7 or G8 score ≤ 14
  • Nutritional Risk Screening tool (NRS 2002) > 3
  • Elective colonic or rectal resection
  • Minimally invasive surgical approach (laparoscopic or robotic)
  • Patients discharged to own home
  • Informed consent to participate

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elna A. Dalsgaard, ph.d. student contact

+45 42402296

elna.adalsteinsdottir.dalsgaard@regionh.dk

Jacob Rosenberg, Professor, dr.med. contact

jacob.rosenberg@regionh.dk

Denmark2 sites, 2 recruiting
  • University Hospital Herlev

    Herlev, 2730

    Elna A. Dalsgaard, ph.d.-student, +45 42402296, elna.adalsteinsdottir.dalsgaard@regionh.dk

    Not yet recruiting
  • University Hospital Herlev

    Herlev, 2730

    Elna Dalsgaard, +45 42402296, elna.adalsteinsdottir.dalsgaard@regionh.dk

    Recruiting

Other trials in Denmark

About this study

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.

Being tested
ERAS 3.0 (Enhanced Recovery After Surgery)
Keywords
ERAS 3.0, colon cancer surgery, comprehensive geriatric assessment
Medical subject headings
Colonic Neoplasms, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERAS 3.0 (Enhanced Recovery After Surgery)Other

    Nutritional support at discharge and home visits which include comprehensive geriatric assessment, nutritional guidance by dietitian, and instructions on exercise and physical activity.

Study groups in NCT06802991
Study groupRoleWhat they receive
ERAS 3.0 groupExperimentalPost-surgery support at discharge and at home
Receives: Other: ERAS 3.0 (Enhanced Recovery After Surgery)
Standard care groupNo interventionStandard care, which is no support after discharge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10-14 days after surgery

Secondary outcomes (15)
  1. 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.

    Measured: 12, 30 and 90 days after surgery

  2. 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.

    Measured: 30 and 90 days after surgery

  3. 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.

    Measured: 12, 30 and 90 days after surgery

  4. 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.

    Measured: 12, 30 and 90 days after surgery

  5. 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.

    Measured: 12, 30 and 90 days after surgery

  6. Weight

    Measured: 12, 30 and 90 days after surgery

  7. 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.

    Measured: 12, 30 and 90 days after surgery

  8. 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.

    Measured: 12, 30 and 90 days after surgery as well as 1 (CT) and 3 (CT) years after surgery

  9. Rate of readmission

    Readmission rate is defined as any unplanned hospitalisation within 30 days after discharge from hospital.

    Measured: within 30 days after discharge

  10. Postoperative complications

    The occurrence of post-operative complications, including infections requiring treatment within 30 and 90 days will be registered numerically.

    Measured: within 30 and 90 days after discharge

  11. Number of reoperations

    The occurence of reoperations will be registered

    Measured: within 1 and 6 months after discharge

  12. Total length of hospital stay

    Measured: within 6 months after discharge

  13. Days alive and out of the hospital

    Measured: within 30 and 90 days after discharge

  14. Mortality

    Measured: Within 1, 3, 6, and 12 months after primary surgery

  15. 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.

    Measured: at baseline, after one and three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2025
  2. Study start1 Apr 2025
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion20 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06802991
Sponsor's protocol ID
H-24078496
Status last verified
Oct 2026
First submitted
19 Jan 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 33516195

Questions about this trial

What is this clinical trial studying?

A study testing ERAS 3.0 (Enhanced Recovery After Surgery) in people with Colon Cancer and Frailty, run by Copenhagen University Hospital at Herlev at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elna A. Dalsgaard, ph.d. student (+45 42402296, elna.adalsteinsdottir.dalsgaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative recovery (time frame: 10-14 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06802991, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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