Complication,PostoperativeOPTNCT04909567
Optimization of Patients' Physical and Mental Status Prior to Colorectal Cancer Surgery
A study testing Optimisation in people with Complication,Postoperative and ERAS, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication,Postoperative, ERAS
- What is being tested?
- Optimisation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- 1 siteSweden
- Study dates
- 26 Oct 2021to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients, 18 years or older, with strong suspicion of colorectal cancer
Who cannot join
- Patients with dementia with severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Ulf Oskar Gustafsson
Stockholm, 18288
Ulf Gustafsson, 46706073828, ulf.o.gustafsson@regionstockholm.se
About this study
Official 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.
Read the detailed description
A randomized controlled, unblinded study with block stratification for surgical procedures.
Intervention arm:
All patients in the intervention group will be treated in an "optimization center" which constitutes its own physical location at the hospital and functions as a day care unit staffed with doctors, contact nurses, physiotherapists, ERAS nurses and dietitians. An expert team of cardiologists, physiologists, renal physicians and endocrinologists are attached to the unit.
Day 1. (2-12 weeks before the operation). Multipel testing: Clinical status, ASA score, NSQIP score. Alcohol and Smoke score tests. Nutritional score. 6 minute walk test. Psychiatric score tests. If mortality risk >5% according to NSQIP, low performance on walk test, chair stand test. ASA 3-4, HbA1c >50 for non diabetics, >60 for diabetics or (GFR <45) = special attention from the expert team.
Day 2 until one week before surgery:
Home exercise 5 days / week. Organised (physiotherapist) exercise 2 days / week. Dietprogram with close follow-up. Psychosocial support. Smoking and alcohol cessation program
The week before surgery: The same tests as day 1. 30 days posted: The same tests as day 1.
Controlarm: The same tests as for the intervention group, day 1, the week before surgery and 30 days post. No interventions during the period.
The international ERAS database will be used to record data in the study. Consecutive registration of over 300 perioperative variables on each individual patient.
Examples of these variables are basic patient characteristics, preoperative variables such as information before surgery, laxation, nutrition, fluid intake, anemia and glucose optimization. Intraoperative variables such as body temperature, fluid supply, anesthesia method, bleeding, operation time and gastric tube. Postoperative variables such as catheter removal, nutrition, mobilization, nausea, paralytic ileus, specified complications, reoperations and length of stay after surgery. Compliance with the ERAS protocol will be registered.
- Conditions
- Complication,Postoperative, ERAS
- Being tested
- Optimisation
- Keywords
- ERAS, RCT, Optimisation
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptimisationBehavioural
Defined optimisation
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Optimisation:
Diet, organised exercise, psychosocial support Receives: Behavioral: Optimisation |
| Control arm | No intervention | Current standard preparation before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (5)
Reoperations
Change of proportion of reoperations in intervention vs. control arm
Measured: 30 days
Length of stay (LOS)
Change of LOS (days) in intervention vs. control arm
Measured: 30 days
Working capacity
Change of walking distance (meter) in intervention vs. control arm (6 minute walk test)
Measured: 2-12 weeks
Weight loss
Change of weight loss (kg) in intervention vs. control arm
Measured: 2-12 weeks
Psychosocial status
Change of points in Hospital and Anxiety scale (HAD) in intervention vs. control arm
Measured: 2-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start26 Oct 2021
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication,PostoperativeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 518 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulf Oskar Gustafsson, MD, PhD, Karolinska Institutet
- Investigators
- Ulf Gustafsson, MD, PhD, Principal investigator, Karolinska InstitutetJosefin Karlsson, Nurse, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909567
- Sponsor's protocol ID
- RCT: OPTIMIZATION: 2021:9
- Acronym
- OPT
- Status last verified
- Mar 2023
- First submitted
- 26 May 2021
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Bjerregaard F, Pekkari K, Asklid D, Anderin C, Westberg K, Marsk R, Gustafsson UO. Multimodal prehabilitation in colorectal cancer surgery: randomized clinical trial. BJS Open. 2026 Sep 4;10(5):zrag167. doi: 10.1093/bjsopen/zrag167.
PubMed 42925093
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Patients' Physical and Mental Status Prior to Colorectal Cancer Surgery -a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04909567
- Acronym / sponsor ID
- OPT / RCT: OPTIMIZATION: 2021:9
- Conditions
- Complication,Postoperative, ERAS
- Keywords
- ERAS, RCT, Optimisation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 518 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized controlled, unblinded study with block stratification for surgical procedures.
Intervention arm:
All patients in the intervention group will be treated in an "optimization center" which constitutes its own physical location at the hospital and functions as a day care unit staffed with doctors, contact nurses, physiotherapists, ERAS nurses and dietitians. An expert team of cardiologists, physiologists, renal physicians and endocrinologists are attached to the unit.
Day 1. (2-12 weeks before the operation). Multipel testing: Clinical status, ASA score, NSQIP score. Alcohol and Smoke score tests. Nutritional score. 6 minute walk test. Psychiatric score tests. If mortality risk >5% according to NSQIP, low performance on walk test, chair stand test. ASA 3-4, HbA1c >50 for non diabetics, >60 for diabetics or (GFR <45) = special attention from the expert team.
Day 2 until one week before surgery:
Home exercise 5 days / week. Organised (physiotherapist) exercise 2 days / week. Dietprogram with close follow-up. Psychosocial support. Smoking and alcohol cessation program
The week before surgery: The same tests as day 1. 30 days posted: The same tests as day 1.
Controlarm: The same tests as for the intervention group, day 1, the week before surgery and 30 days post. No interventions during the period.
The international ERAS database will be used to record data in the study. Consecutive registration of over 300 perioperative variables on each individual patient.
Examples of these variables are basic patient characteristics, preoperative variables such as information before surgery, laxation, nutrition, fluid intake, anemia and glucose optimization. Intraoperative variables such as body temperature, fluid supply, anesthesia method, bleeding, operation time and gastric tube. Postoperative variables such as catheter removal, nutrition, mobilization, nausea, paralytic ileus, specified complications, reoperations and length of stay after surgery. Compliance with the ERAS protocol will be registered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: OptimisationOptimisation: Diet, organised exercise, psychosocial support |
| Control arm | No intervention | –Current standard preparation before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients, 18 years or older, with strong suspicion of colorectal cancer
Key exclusion criteria (1 listed)
- Patients with dementia with severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptimisationDefined optimisation | Behavioural | Intervention arm |
Primary outcome
Serious complications
Time frame: 30 days
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
5 secondary outcomes
Reoperations
Time frame: 30 days
Length of stay (LOS)
Time frame: 30 days
Working capacity
Time frame: 2-12 weeks
Weight loss
Time frame: 2-12 weeks
Psychosocial status
Time frame: 2-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Derived from this study: PubMed 42925093Bjerregaard F, Pekkari K, Asklid D, Anderin C, Westberg K, Marsk R, Gustafsson UO. Multimodal prehabilitation in colorectal cancer surgery: randomized clinical trial. BJS Open. 2026 Sep 4;10(5):zrag167. doi: 10.1093/bjsopen/zrag167.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Gustafsson, MD, PhD principal investigator
Karolinska Institutet
Josefin Karlsson, Nurse study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimisation in people with Complication,Postoperative and ERAS, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klas Pekkari, MD, PhD, (46707799817, klas.pekkari@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04909567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.