Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2025
CompletedFirst Posted
Study publicly available on registry
January 31, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 20, 2029
March 18, 2026
March 1, 2026
1.7 years
January 19, 2025
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
10-14 days after surgery
Secondary Outcomes (15)
Health realted Quality of Life (HrQoL)
12, 30 and 90 days after surgery
Postoperative recovery
30 and 90 days after surgery
Activities of daily living
12, 30 and 90 days after surgery
Energy- and protein intake
12, 30 and 90 days after surgery
Appetite
12, 30 and 90 days after surgery
- +10 more secondary outcomes
Study Arms (2)
ERAS 3.0 group
EXPERIMENTALPost-surgery support at discharge and at home
Standard care group
NO INTERVENTIONStandard care, which is no support after discharge
Interventions
Nutritional support at discharge and home visits which include comprehensive geriatric assessment, nutritional guidance by dietitian, and instructions on exercise and physical activity.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Copenhagen University Hospital at Herlevlead
- Danish Cancer Societycollaborator
Study Sites (2)
University Hospital Herlev
Herlev, 2730, Denmark
University Hospital Herlev
Herlev, 2730, Denmark
Related Publications (2)
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: 34656032BACKGROUNDDolin 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: 33516195BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jacob Rosenberg, Professor, dr. med.
Center of Perioperative Optimisation, Copenhagen University Hospital at Herlev
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc, ph.d. student
Study Record Dates
First Submitted
January 19, 2025
First Posted
January 31, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
December 20, 2029
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share