Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)
NCT ID: NCT06802991
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-04-01
2029-12-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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ERAS 3.0 group
Post-surgery support at discharge and at home
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.
Standard care group
Standard care, which is no support after discharge
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Danish Cancer Society
OTHER
Copenhagen University Hospital at Herlev
OTHER
Responsible Party
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Elna A. Dalsgaard
MSc, ph.d. student
Principal Investigators
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Jacob Rosenberg, Professor, dr. med.
Role: STUDY_DIRECTOR
Center of Perioperative Optimisation, Copenhagen University Hospital at Herlev
Locations
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University Hospital Herlev
Herlev, , Denmark
University Hospital Herlev
Herlev, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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H-24078496
Identifier Type: -
Identifier Source: org_study_id
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