C18 R68.8 C19 C20
Conditions
Interventions
Group 1: Arm A (experimental): Multidisciplinary geriatric ward
Group 2: Arm B (control): Contemporary surgical ward
Sponsors
KLINIKUM ASCHAFFENBURG, CHIRURGISCHE KLINIK I, ALLGEMEIN-, VISZERAL- UND GEFÄSSCHIRURGIE
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. age =70 years old; 2. diagnosis of colorectal cancer; 3. scheduled for elective surgery (for that colorectal cancer); 4. willingness to accept study allocation to either the surgical or the multidisciplinary geriatric ward; 5. Capacity to provide written informed consent; 6. BRASS Score =10.
Exclusion criteria
Exclusion criteria: 1. a history of prior surgery for colorectal cancer 2. acute colon surgery cases; 3. patients requiring emergency surgery; 4. palliative surgery cases (surgery with the intention of improving quality of life for advanced non-curable disease); 5. nursing home residents requiring full nursing care on admission corresponding to a BRASS Score >30; 6. dementia or other cognitive impairment – at the time of the eligibility screening – sufficient to make completion of the study questionnaires impossible even with the full support of a study nurse; 7. lack of written informed consent; 8. the operating surgeon makes a decision, at the end of the operation and just prior to randomization, that the patient needs post-operative care on the ICU and is not fit for randomization to immediate post-op treatment on either the standard surgical ward or the multidisciplinary geriatric ward, (cf. the section on randomization).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cost-efficacy, measured as all treatment costs, on the 1st to 30th days post-op, divided by the quality-adjusted life-years for the first 30 days post-op, based on the EQ-5D-5L assessed at discharge and extrapolated forward and backward across the month. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient-reported outcomes at discharge: physical function (PROMIS short v.2.0 Physical Function 4a), independence of self-care (Katz ADL), pain (VAS), satisfaction (VAS), mental health (BSI-18), general QoL (EQ-5D-5L), disease-specific QoL (EORTS QLQ CR29). 2. Medical outcomes at discharge: change of BMI, muscle strength (grip dynamometer), muscle performance (chair stand test), mobility (time to walk 5m), nutrition (SNAQ), cognitive status (MMSE). 3. Administrative outcomes: length of post-op stay, type of residence for discharge. 4. Financial outcomes: total cost of 30-day post-op care not due to preexisting chronic conditions or other preplanned treatments. 5. Safety outcomes: 30-day mortality; 30-day SAEs (frequency & severity), 30-day infection rate, 30-day morbidity (POMS), 30-day readmission rate, 30-day reoperation rate. | — |
Countries
Germany
Contacts
Public ContactGeorge-Octavian Popescu
KLINIKUM ASCHAFFENBURG, CHIRURGISCHE KLINIK I, ALLGEMEIN-, VISZERAL- UND GEFÄSSCHIRURGIE
Outcome results
None listed