Clinical trial · Interventional
Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Frailty | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ERAS 3.0 (Enhanced Recovery After Surgery) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ERAS 3.0 group
- description
- Post-surgery support at discharge and at home
- interventionNames
- Other: ERAS 3.0 (Enhanced Recovery After Surgery)
- type
- NO_INTERVENTION
- label
- Standard care group
- description
- Standard care, which is no support after discharge
Primary outcomes (1)
- measure
- Postoperative recovery
- timeFrame
- 10-14 days after surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDMunk 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
- BACKGROUNDDolin 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