Clinical trial NCT06802991: Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)
Official title: Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Frailty
Keywords: ERAS 3.0
colon cancer surgery
comprehensive geriatric assessment
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2025-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative recovery
timeFrame: 10-14 days after surgery
Secondary outcomes:
measure: Health realted Quality of Life (HrQoL)
timeFrame: 12, 30 and 90 days after surgery
measure: Postoperative recovery
timeFrame: 30 and 90 days after surgery
measure: Activities of daily living
timeFrame: 12, 30 and 90 days after surgery
measure: Energy- and protein intake
timeFrame: 12, 30 and 90 days after surgery
measure: Appetite
timeFrame: 12, 30 and 90 days after surgery
measure: Weight
timeFrame: 12, 30 and 90 days after surgery
measure: Physical function and muscle strenght
timeFrame: 12, 30 and 90 days after surgery
measure: Muscle mass by BIA
timeFrame: 12, 30 and 90 days after surgery as well as 1 (CT) and 3 (CT) years after surgery
measure: Rate of readmission
timeFrame: within 30 days after discharge
measure: Postoperative complications
timeFrame: within 30 and 90 days after discharge
measure: Number of reoperations
timeFrame: within 1 and 6 months after discharge
measure: Total length of hospital stay
timeFrame: within 6 months after discharge
measure: Days alive and out of the hospital
timeFrame: within 30 and 90 days after discharge
measure: Mortality
timeFrame: Within 1, 3, 6, and 12 months after primary surgery
measure: Muscle mass by CT
timeFrame: at baseline, after one and three years
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: University Hospital Herlev
city: Herlev
country: Denmark
facility: University Hospital Herlev
Study officials:
affiliation: Center of Perioperative Optimisation, Copenhagen University Hospital at Herlev
name: Jacob Rosenberg, Professor, dr. med.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.