Optimization of Patients' Physical and Mental Status Prior to Colorectal Cancer Surgery
OPT
1 other identifier
interventional
518
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2021
CompletedFirst Posted
Study publicly available on registry
June 1, 2021
CompletedStudy Start
First participant enrolled
October 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedMarch 10, 2023
March 1, 2023
3.9 years
May 26, 2021
March 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Reoperations
30 days
Length of stay (LOS)
30 days
Working capacity
2-12 weeks
Weight loss
2-12 weeks
Psychosocial status
2-12 weeks
Study Arms (2)
Intervention arm
EXPERIMENTALOptimisation: Diet, organised exercise, psychosocial support
Control arm
NO INTERVENTIONCurrent standard preparation before surgery
Interventions
Eligibility Criteria
You may qualify if:
- All patients, 18 years or older, with strong suspicion of colorectal cancer
You may not qualify if:
- Patients with dementia with severe cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ulf Oskar Gustafsson
Stockholm, 18288, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ulf Gustafsson, MD, PhD
Karolinska Institutet
- STUDY CHAIR
Josefin Karlsson, Nurse
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Surgery
Study Record Dates
First Submitted
May 26, 2021
First Posted
June 1, 2021
Study Start
October 26, 2021
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
March 10, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share
Data Availability Statement Due to Swedish legal restrictions and the current ethical approval for the study, data is not publicly available to share, but the research group can provide descriptive data in table form.