Colorectal CancerCanOptiPhysNCT04878185
Optimizing Physical Function Before Cancer Surgery in Older People at Risk
A study testing Exercise in people with Colorectal Cancer and Postoperative Complications, run by Karolinska Institutet at 4 sites in Sweden.
Trial summary
This randomized controlled trial is a multicentre study designed to explore the effects of preoperative exercise on physical fitness, postoperative complications, recovery, and health-related quality of life in older individuals at risk scheduled to undergo colorectal cancer surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colorectal Cancer, Postoperative Complications
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 4 sitesSweden
- Study dates
- 10 May 2021to 30 Jun 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Scheduled surgery due to colorectal cancer or liver metastases from colorectal cancer
- Age ≥65
- A maximal walking speed below 2 meters per second
- Understands and speaks the Swedish language
Who cannot join
- Planned hyperthermic intraperitoneal chemotherapy (HIPEC) procedure or flap surgery
- Health conditions that prevent participation in assessment or exercise. Such conditions include, but are not limited to, unstable heart disease, severe systematic illness or orthopaedic conditions that may prohibit exercise.
- The need for surgery within 2 weeks
- Permanent wheelchair user
- Residence outside of Stockholm County
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Karolinska University Hospital Huddinge
Huddinge, Karolinska Institutet, 14183
Karolinska University Hospital Solna
Stockholm, 171 76
Ersta hospital
Stockholm
Stockholm South General Hospital
Stockholm
About this study
Official title: Optimizing Physical Function Before Surgery: Effects on Complications and Physical Function After Gastrointestinal Cancer Surgery in Older People at Risk- A Randomized Controlled Trial
This randomized controlled trial is a multicentre study designed to explore the effects of preoperative exercise on physical fitness, postoperative complications, recovery, and health-related quality of life in older individuals at risk scheduled to undergo colorectal cancer surgery. The hypothesis is that older patients with low preoperative physical capacity will benefit from preoperative exercise in terms of lower risk for postoperative complications and improved recovery after surgery.
Read the detailed description
Reduced physical capacity and performance associated with advancing age may decrease the ability to withstand the strain of a major surgical intervention. Exercise prior to surgery is a key component of prehabilitation. The goal of prehabilitation is to enhance preoperative physical fitness to attenuate postoperative decline and possibly decrease the risk of postoperative complications.
A previous observational study showed that better preoperative physical performance in measures of walking distance, leg strength, inspiratory muscle strength and maximal gait speed reduced the risk of severe postoperative complications for older patients undergoing abdominal cancer surgery. Furthermore, gait speed has been suggested to add information to current preoperative risk screening, where a cut of value of a maximal gait speed below 2 meters/second indicates a higher risk for postoperative complications.
This planned trial will be conducted in cooperation with the Karolinska University Hospital, Ersta Hospital, The Stockholm South General Hospital and several primary care units in Stockholm. To target older patients at risk, patients aged 65 and older with a maximal gait speed under 2 meters/second will be included. Participants will be randomized to either intervention- or control group and trained physiotherapists or nurses from the hospitals, will conduct the assessments. All baseline measures will be collected before randomization.
The implementation of standardized cancer care pathways in Sweden has led to reduced time between diagnosis to curative treatment. For colorectal surgery, the time from decision to treatment is set to two weeks. Therefore, an exercise program aimed to enhance physical function prior to surgery require a high intensity and high frequency approach. The exercise program will be home-based and consist of inspiratory muscle training, endurance- and strength exercise under the supervision of trained physiotherapists from primary care units. To assess feasibility of the planned intervention, a pilot study was conducted. The results showed high compliance and acceptability among the participants which provides a starting point for this larger study designed to explore the effects of preoperative exercise on:
- Preoperative physical function in a short-term perspective
- Postoperative complications and functional decline
- Length of in-hospital stay, mortality, health-related quality of life, physical activity level and independency in activities in daily living in a long-term perspective
- Conditions
- Colorectal Cancer, Postoperative Complications
- Being tested
- Exercise
- Keywords
- Preoperative Exercise
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Preoperative exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | A high-intensity, home-based, exercise program consisting of inspiratory muscle training (IMT), endurance- and functional strength exercise. The sessions will supervised by a physiotherapist during six occasions and start 2-3 weeks before surgery. IMT will be conducted with an intensity starting from 50 % of maximal capacity, with a self-reported effort of 5-7 on the Borgs CR-10 scale. Endurance and functional strength exercises will be performed at a self-reported effort of 7-8. Interval training, chair stand- and step-up exercises will be key components of the exercise program. Furthermore, the program will include task-specific exercises based on the participants self-expressed needs.
On non-supervised days, participants will perform IMT twice a day as well as endurance and strength training, 2-3 days per week with 1-2 days per week of active recovery in the form of moderate intensity walks. This will be monitored with an activity journal and an accelerometer. Receives: Other: Exercise |
| Control group | No intervention | Participants in the control group receive pre- and postoperative care as usual. In addition, they will be encouraged to follow the WHO guidelines of moderate intensity aerobic physical activity for at least 150 min per week. Their activity level will be monitored with an accelerometer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Postoperative Complications 30 days post-surgery
The Clavien-Dindo classification system will be used to describe the occurence of post-operative complications.
Measured: 30 days post-surgery
Change in maximal walking distance
The 6-minute walk test will be used to assess physical endurance. The test requires subjects to walk as far as possible during 6 minutes. Outcome is metres walked.
Measured: Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days)
Secondary outcomes (11)
Length of hospital stay
The number of days spent at hospital. Data will be collected from the medical records. Outcome is number of days.
Measured: Baseline (day of hospital admission), day of hospital discharge (average: 5 days)
Quality of life as assessed by the EORTC QLQ-C30
The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 (EORTC QLQ-C30) and the supplemental Elderly Cancer Patients Module will be used to assess quality of life. The scale is comprised of nine subscales: one global health status scale, five functioning scales and three symptom scales. The scales range from 0-100 scores. Higher scores for the global health status scale and functioning scales indicate better outcomes. For the symptom scales, higher scores indicate worse outcomes.
Measured: Baseline, 6 and 12 months post-surgery
Quality of life as assessed by the EORTC QLQ-ELD14
The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire for the Elderly Cancer Patients Module (EORTC QLQ-ELD14) will be used to assess quality of life. The scale is comprised of five subscales: mobility, family support, worries about the future, maintaining autonomy and purpose, and burden of illness. The scales range from 0-100 scores. For the family support scale and the autonomy and purpose scale, higher scores indicate better outcomes. For the mobility, worries and burden of illness scales, higher scores indicate worse outcomes.
Measured: Baseline, 6 and 12 months post-surgery
Destination of discharge from the hospital
Data on destination of discharge will be collected from the medical journal. The information will be categorized into home, rehabilitation facility or further care (in e.g a geriatric clinic or residential care).
Measured: Day of hospital discharge (average: 5 days)
Patient-reported symptoms
The Postoperative Recovery Profile. The scale consists of physical symptoms, physical function, psychological and social impact and activity. The results are divided in 5 categories from not recovered at all to fully recovered.
Measured: 2-3 days post-surgery, day of hospital discharge (average: 5 days), and 6 months post-surgery
Delirium
Confusion Assessment Method consists of 9 item, if you fulfill one of the items 1-4, you are diagnosed with confusion.
Measured: 2-3 days post-surgery
Change in lower extremity strength
The 30-second chair stand test will be used to measure functional lower extremity strength. Outcome is the number of times the patient comes to a full standing position in 30 seconds.
Measured: Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days)
Change in maximal inspiratory muscle strength
Micro respiratory pressure meter is measured using the MicroRPM.
Measured: Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days)
Level of independence in daily living
The ADL-staircase is an hierarchical scale with 10 items including both personal and instrumental activities ranging from inpedendent to dependent.
Measured: Baseline, 6 and 12 months post-surgery
Physical activity level
Physical Activity Scale for the Elderly includes time spent in sitting, exercise, leisure, household/gardening and work/voluntary activities. It scores from 0 to 400, higher score indicate higher activity level.
Measured: Baseline, 6 and 12 months post-surgery
Mortality
Mortality data will be collected from medical records.
Measured: Baseline (post-surgery), 12, 24, and 36 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start10 May 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth Rydwik, Karolinska Institutet
- Investigators
- Elisabeth Rydwik, Assoc prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878185
- Sponsor's protocol ID
- EPN2015/1179-31
- Acronym
- CanOptiPhys
- Status last verified
- Oct 2023
- First submitted
- 6 Apr 2021
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is not publicly available, but available upon request.
Publications
American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.
PubMed 19516148Topp R, Ditmyer M, King K, Doherty K, Hornyak J 3rd. The effect of bed rest and potential of prehabilitation on patients in the intensive care unit. AACN Clin Issues. 2002 May;13(2):263-76. doi: 10.1097/00044067-200205000-00011.
PubMed 12011598Karlsson E, Egenvall M, Farahnak P, Bergenmar M, Nygren-Bonnier M, Franzen E, Rydwik E. Better preoperative physical performance reduces the odds of complication severity and discharge to care facility after abdominal cancer resection in people over the age of 70 - A prospective cohort study. Eur J Surg Oncol. 2018 Nov;44(11):1760-1767. doi: 10.1016/j.ejso.2018.08.011. Epub 2018 Aug 29.
PubMed 30201418American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
PubMed 19204579Katsura M, Kuriyama A, Takeshima T, Fukuhara S, Furukawa TA. Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD010356. doi: 10.1002/14651858.CD010356.pub2.
PubMed 26436600Danielsson J, Engstrom Sid J, Andersson M, Nygren-Bonnier M, Egenvall M, Hagstromer M, Vossen LE, Dohrn IM, Rydwik E. Optimizing Physical Fitness Before Colorectal Cancer Surgery (CANOPTIPHYS): The Effect of Preoperative Exercise on Pre- and Postoperative Physical Fitness in Older people - A Randomized Controlled Trial. J Prim Care Community Health. 2025 Jan-Dec;16:21501319251346417. doi: 10.1177/21501319251346417. Epub 2025 Jun 17.
PubMed 40525350Andersson M, Egenvall M, Danielsson J, Thorell A, Sturesson C, Soop M, Nygren-Bonnier M, Rydwik E. CANOPTIPHYS study protocol: Optimising PHYSical function before CANcer surgery: effects of pre-operative optimisation on complications and physical function after gastrointestinal cancer surgery in older people at risk-a multicentre, randomised, parallel-group study. Trials. 2023 Jan 19;24(1):41. doi: 10.1186/s13063-022-07026-w.
PubMed 36658653
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Physical Function Before Surgery: Effects on Complications and Physical Function After Gastrointestinal Cancer Surgery in Older People at Risk- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04878185
- Acronym / sponsor ID
- CanOptiPhys / EPN2015/1179-31
- Conditions
- Colorectal Cancer, Postoperative Complications
- Keywords
- Preoperative Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 7 May 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.
This randomized controlled trial is a multicentre study designed to explore the effects of preoperative exercise on physical fitness, postoperative complications, recovery, and health-related quality of life in older individuals at risk scheduled to undergo colorectal cancer surgery. The hypothesis is that older patients with low preoperative physical capacity will benefit from preoperative exercise in terms of lower risk for postoperative complications and improved recovery after surgery.
Detailed description
Reduced physical capacity and performance associated with advancing age may decrease the ability to withstand the strain of a major surgical intervention. Exercise prior to surgery is a key component of prehabilitation. The goal of prehabilitation is to enhance preoperative physical fitness to attenuate postoperative decline and possibly decrease the risk of postoperative complications.
A previous observational study showed that better preoperative physical performance in measures of walking distance, leg strength, inspiratory muscle strength and maximal gait speed reduced the risk of severe postoperative complications for older patients undergoing abdominal cancer surgery. Furthermore, gait speed has been suggested to add information to current preoperative risk screening, where a cut of value of a maximal gait speed below 2 meters/second indicates a higher risk for postoperative complications.
This planned trial will be conducted in cooperation with the Karolinska University Hospital, Ersta Hospital, The Stockholm South General Hospital and several primary care units in Stockholm. To target older patients at risk, patients aged 65 and older with a maximal gait speed under 2 meters/second will be included. Participants will be randomized to either intervention- or control group and trained physiotherapists or nurses from the hospitals, will conduct the assessments. All baseline measures will be collected before randomization.
The implementation of standardized cancer care pathways in Sweden has led to reduced time between diagnosis to curative treatment. For colorectal surgery, the time from decision to treatment is set to two weeks. Therefore, an exercise program aimed to enhance physical function prior to surgery require a high intensity and high frequency approach. The exercise program will be home-based and consist of inspiratory muscle training, endurance- and strength exercise under the supervision of trained physiotherapists from primary care units. To assess feasibility of the planned intervention, a pilot study was conducted. The results showed high compliance and acceptability among the participants which provides a starting point for this larger study designed to explore the effects of preoperative exercise on:
- Preoperative physical function in a short-term perspective
- Postoperative complications and functional decline
- Length of in-hospital stay, mortality, health-related quality of life, physical activity level and independency in activities in daily living in a long-term perspective
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseA high-intensity, home-based, exercise program consisting of inspiratory muscle training (IMT), endurance- and functional strength exercise. The sessions will supervised by a physiotherapist during six occasions and start 2-3 weeks before surgery. IMT will be conducted with an intensity starting from 50 % of maximal capacity, with a self-reported effort of 5-7 on the Borgs CR-10 scale. Endurance and functional strength exercises will be performed at a self-reported effort of 7-8. Interval training, chair stand- and step-up exercises will be key components of the exercise program. Furthermore, the program will include task-specific exercises based on the participants self-expressed needs. On non-supervised days, participants will perform IMT twice a day as well as endurance and strength training, 2-3 days per week with 1-2 days per week of active recovery in the form of moderate intensity walks. This will be monitored with an activity journal and an accelerometer. |
| Control group | No intervention | –Participants in the control group receive pre- and postoperative care as usual. In addition, they will be encouraged to follow the WHO guidelines of moderate intensity aerobic physical activity for at least 150 min per week. Their activity level will be monitored with an accelerometer. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Scheduled surgery due to colorectal cancer or liver metastases from colorectal cancer
- Age ≥65
- A maximal walking speed below 2 meters per second
- Understands and speaks the Swedish language
Key exclusion criteria (5 listed)
- Planned hyperthermic intraperitoneal chemotherapy (HIPEC) procedure or flap surgery
- Health conditions that prevent participation in assessment or exercise. Such conditions include, but are not limited to, unstable heart disease, severe systematic illness or orthopaedic conditions that may prohibit exercise.
- The need for surgery within 2 weeks
- Permanent wheelchair user
- Residence outside of Stockholm County
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 |
|---|---|---|
| ExercisePreoperative exercise | Other | Exercise |
Primary outcome
Number of participants with Postoperative Complications 30 days post-surgery
Time frame: 30 days post-surgery
The Clavien-Dindo classification system will be used to describe the occurence of post-operative complications.
Change in maximal walking distance
Time frame: Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days)
The 6-minute walk test will be used to assess physical endurance. The test requires subjects to walk as far as possible during 6 minutes. Outcome is metres walked.
11 secondary outcomes
Length of hospital stay
Time frame: Baseline (day of hospital admission), day of hospital discharge (average: 5 days)
Quality of life as assessed by the EORTC QLQ-C30
Time frame: Baseline, 6 and 12 months post-surgery
Quality of life as assessed by the EORTC QLQ-ELD14
Time frame: Baseline, 6 and 12 months post-surgery
Destination of discharge from the hospital
Time frame: Day of hospital discharge (average: 5 days)
Patient-reported symptoms
Time frame: 2-3 days post-surgery, day of hospital discharge (average: 5 days), and 6 months post-surgery
Delirium
Time frame: 2-3 days post-surgery
Change in lower extremity strength
Time frame: Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days)
Change in maximal inspiratory muscle strength
Time frame: Baseline, completion immediately after intervention, and day of hospital discharge (average: 5 days)
Level of independence in daily living
Time frame: Baseline, 6 and 12 months post-surgery
Physical activity level
Time frame: Baseline, 6 and 12 months post-surgery
Mortality
Time frame: Baseline (post-surgery), 12, 24, and 36 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Background: PubMed 19516148American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.
- Background: PubMed 12011598Topp R, Ditmyer M, King K, Doherty K, Hornyak J 3rd. The effect of bed rest and potential of prehabilitation on patients in the intensive care unit. AACN Clin Issues. 2002 May;13(2):263-76. doi: 10.1097/00044067-200205000-00011.
- Background: PubMed 30201418Karlsson E, Egenvall M, Farahnak P, Bergenmar M, Nygren-Bonnier M, Franzen E, Rydwik E. Better preoperative physical performance reduces the odds of complication severity and discharge to care facility after abdominal cancer resection in people over the age of 70 - A prospective cohort study. Eur J Surg Oncol. 2018 Nov;44(11):1760-1767. doi: 10.1016/j.ejso.2018.08.011. Epub 2018 Aug 29.
- Background: PubMed 19204579American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
- Background: PubMed 26436600Katsura M, Kuriyama A, Takeshima T, Fukuhara S, Furukawa TA. Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD010356. doi: 10.1002/14651858.CD010356.pub2.
- Derived from this study: PubMed 40525350Danielsson J, Engstrom Sid J, Andersson M, Nygren-Bonnier M, Egenvall M, Hagstromer M, Vossen LE, Dohrn IM, Rydwik E. Optimizing Physical Fitness Before Colorectal Cancer Surgery (CANOPTIPHYS): The Effect of Preoperative Exercise on Pre- and Postoperative Physical Fitness in Older people - A Randomized Controlled Trial. J Prim Care Community Health. 2025 Jan-Dec;16:21501319251346417. doi: 10.1177/21501319251346417. Epub 2025 Jun 17.
- Derived from this study: PubMed 36658653Andersson M, Egenvall M, Danielsson J, Thorell A, Sturesson C, Soop M, Nygren-Bonnier M, Rydwik E. CANOPTIPHYS study protocol: Optimising PHYSical function before CANcer surgery: effects of pre-operative optimisation on complications and physical function after gastrointestinal cancer surgery in older people at risk-a multicentre, randomised, parallel-group study. Trials. 2023 Jan 19;24(1):41. doi: 10.1186/s13063-022-07026-w.
- Individual participant dataSharing planned: Yes. Data is not publicly available, but available upon request.
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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.
Elisabeth Rydwik, Assoc prof principal investigator
Karolinska Institutet
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Colorectal Cancer and Postoperative Complications, run by Karolinska Institutet at 4 sites 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 4 inclusion and 5 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 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Postoperative Complications 30 days post-surgery (time frame: 30 days post-surgery). The study lists 2 primary outcomes in all. 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 NCT04878185, which also lists 7 linked publications.
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 19 Oct 2023.