ERAS Clinical Trial
— OPTOfficial title:
Optimization of Patients' Physical and Mental Status Prior to Colorectal Cancer Surgery -a Randomized Clinical Trial
Colorectal cancer is one of the most common cancers globally. A majority are operated on for the purpose of cure. Complications after surgery are common, involve long length of stay and increase the risk of later recurrence of cancer. Optimization of physical and mental function before surgery can reduce the risk of complications and provide a faster recovery. However, a standardized form for how optimization should be performed does not exist. At Danderyd Hospital, Stockholm, Sweden, we are starting up an optimization center where patients are offered optimizing measures while waiting for surgery. This form of structured treatment has not been studied before and we therefore want to investigate outcomes in a randomized study. All patients with colorectal cancer who are being examined for surgery are offered participation in the study. Randomization of 518 patients in to either an intervention group where the patients; are optimized for concomitant diseases, treated for malnutrition and overconsumption of alcohol and tobacco, undergoes an exercise program and receives psychosocial support before surgery, or a control group where patients are prepared for surgery according to current routines. Primary outcome is the difference in severe complications between the groups. Secondary outcome is difference in length of stay as well as fitness and mental well-being before and 30 days after the operation.If optimization before surgery reduces complications and shortens length of stay, the model can also be used by other operating specialties. This may result in a great improvement for the healthcare in general.
Status | Recruiting |
Enrollment | 518 |
Est. completion date | September 1, 2025 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients, 18 years or older, with strong suspicion of colorectal cancer Exclusion Criteria: - Patients with dementia with severe cognitive impairment |
Country | Name | City | State |
---|---|---|---|
Sweden | Ulf Oskar Gustafsson | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serious complications | Can preoperative optimization change the proportion of serious complications after surgery (defined according to Clavien 3b-5) in intervention vs. control arm.
) in intervention vs. control arm |
30 days | |
Secondary | Reoperations | Change of proportion of reoperations in intervention vs. control arm | 30 days | |
Secondary | Length of stay (LOS) | Change of LOS (days) in intervention vs. control arm | 30 days | |
Secondary | Working capacity | Change of walking distance (meter) in intervention vs. control arm (6 minute walk test) | 2-12 weeks | |
Secondary | Weight loss | Change of weight loss (kg) in intervention vs. control arm | 2-12 weeks | |
Secondary | Psychosocial status | Change of points in Hospital and Anxiety scale (HAD) in intervention vs. control arm | 2-12 weeks |
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