Optimised Post-discharge Care in Older Patients After Surgery for Colon Cancer (ERAS 3.0)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCopenhagen University Hospital at Herlev
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 65+
Clinical Frailty Scale preoperative score 4-7
Nutritional Risk Screening tool (NRS 2002) > 3
Elective colonic resection
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ERAS 3.0 (Enhanced Recovery After Surgery)
Other interventionNutritional support at discharge and home visits which include comprehensive geriatric assessment, nutritional guidance by dietitian, and instructions on exercise and physical activity.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ERAS 3.0 groupExperimental treatment 1 intervention
Group B: Standard care groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
10-14 days after surgerySecondary outcomes
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.
Time frame
12, 30 and 90 days after surgery2
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.
Time frame
30 and 90 days after surgery3
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.
Time frame
12, 30 and 90 days after surgery4
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.
Time frame
12, 30 and 90 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Copenhagen University Hospital at Herlev
Lead sponsor
Danish Cancer Society
Collaborator
Source ClinicalTrials.gov