Surgical Procedure, UnspecifiedPROFSNCT02626546
Predictors, Risk Factors and Outcome Following Major Surgery
An observational study of Surgical Procedure, Unspecified and Postoperative Complications, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This is a multicentre, prospective, observational cohort study. Consecutive patients, operated in six University Hospitals in Sweden will be recruited following major surgical procedure. The length of patient recruitment period will be 12 weeks. The length of follow up will be 360 days . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified, Postoperative Complications
- What is being tested?
- Major surgical procedure
- Type of treatment
- Surgery or procedure
- How many people
- 1,061 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2015to Sep 2020
- Phase
- Observational
- 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
Study population: Consecutive adult patients who are operated for major surgical procedures during the study period in tertiary hospitals in Sweden.
Who may be able to join
- individuals classified by the American Society of Anesthesiologists Physical Status Classification System (ASA) ≥ 3 AND
- are scheduled for elective or emergency surgical procedure classified as -major OR major/complex by Surgical Outcome Risk Tool (SORT)
- Non eligibility criteria are the following surgical procedures:
- organ transplantation
- immediate trauma
- breast
Show all 13Show fewer
- ear, nose throat
- central nervous system
- cardiac, vascular, pulmonary,
- face, mouth, salivary, thyroidea
- skin, subcutaneous tissue
- endoscopic gastrointestinal
- lack of Swedish identity number
Who cannot join
- patients who refuse the follow up
- patients who are not available for the follow up (living in other countries)
Trial locations and contacts
1 site in 1 country.
About this study
This is a multicentre, prospective, observational cohort study. Consecutive patients, operated in six University Hospitals in Sweden will be recruited following major surgical procedure. The length of patient recruitment period will be 12 weeks. The length of follow up will be 360 days . The objectives are to determine the postoperative morbidity (during the hospital stay), the survival (0-360 days), to identify risk factors for adverse outcomes and to identify risk factors that may potentially be influenced by any intervention in the future.
Amendments:
- The follow-up of mortality is extended to 3 years of the cohort
- The mortality of the background population at 30 and 90 Days will be analyzed
- Validation of the Surgical Outcome Risk Tool in the study cohort and in the background population are planned
Read the detailed description
This is a multicenter, prospective, observational study. Length of patient recruitment is 12 weeks, the length of observation is 360 postoperative days. The expected number of patients is 1000.
Patients will be selected from the operation planning software on each study site. It is done by daily screening of the operation list and will be enrolled by applying the inclusion criteria. The criteria of surgical severity will be assessed by the UK surgical severity grading system ( AXA PPP/ Specialist Procedure Codes, United Kingdom). For that purpose a scroll list will be used, which is available on the website of the Surgical Outcome Risk Tool calculator.
Patient characteristics will be prospectively collected from medical records: age, gender, co-morbidities, medical history, physical activity, blood pressure, heart rate, oxygen saturation and neurological function; routine laboratory findings; type, complexity, urgency of surgery, incision localization and malignancy; lowest intraoperative systolic blood pressure, heart rate. The outcomes are the postoperative morbidity (assessed by the Postoperative Morbidity Survey) classified by the Clavien-Dindo classification tool (during hospital stay), and mortality, use of medications, hospital re-admissions (0-360 days) and new occurrence in different disease related national quality registries.Relationships between postoperative morbidity (POMS) the severity of morbidity (Clavien Dindo) and mortality will be analyzed. For illustration, Kaplan Meyer plots will be used, and for analyses Cox proportional hazard model will be used with adjustment for sex and age.
Additional changes:
- The length of observation for survival was extended to 3 years. The mortality at 3 years will be analyzed addressing the relationship between the postoperative morbidity (POMS) and mortality. Cox regression model will be used with adjustment of age, comorbidity and malignancy.
- Validation of Surgical Outcome Risk Tool is planned in two populations related to the PROFS study: eligible and background population. As the PROFS cohort was manually selected, we presumed that the eligible population is larger than the enrolled population.To enable electronic selection of the eligible population, we have developed a script, which translates the Swedish surgical codes into the UK severity codes. Using the same script we will classify the surgical severity in the background population of the PROFS cohort. Variables included in the Surgical Outcome Risk Tool will be extracted from the operation databases of each study site. The date of death will be extracted from the Swedish National Adress Registry and the malignancy from the registry of National Swedish Cancer Registry.
- Being tested
- Major surgical procedure
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major surgical procedureProcedure or surgery
observation of postoperative outcomes
| Study group | Role | What they receive |
|---|---|---|
| Major surgical procedures | All patients selected to follow up Receives: Procedure: Major surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
postoperative morbidity survey, Clavien Dindo
Measured: 3-10 postoperative days
Secondary outcomes (1)
postoperative mortality
number of deaths at 30, 360 Days AND 3 years
Measured: 30-360 postoperative days and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2016
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,061 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Norrlands University Hospital, Region Örebro County, University Hospital, Linkoeping, Uppsala University Hospital
- Responsible party
- Principal investigator, Sigridur Kalman, Karolinska Institutet
- Investigators
- Sigriduar Kalman, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626546
- Sponsor's protocol ID
- 2015/1128-31/4
- Acronym
- PROFS
- Status last verified
- Sep 2021
- First submitted
- 6 Nov 2015
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors, Risk Factors and Outcome Following Major Surgery
- ClinicalTrials.gov ID
- NCT02626546
- Acronym / sponsor ID
- PROFS / 2015/1128-31/4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,061 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Norrlands University Hospital, Region Örebro County, University Hospital, Linkoeping, Uppsala University Hospital
- Study start
- Nov 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 10 Dec 2015 (estimated)
- 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 is a multicentre, prospective, observational cohort study. Consecutive patients, operated in six University Hospitals in Sweden will be recruited following major surgical procedure. The length of patient recruitment period will be 12 weeks. The length of follow up will be 360 days . The objectives are to determine the postoperative morbidity (during the hospital stay), the survival (0-360 days), to identify risk factors for adverse outcomes and to identify risk factors that may potentially be influenced by any intervention in the future.
Amendments:
- The follow-up of mortality is extended to 3 years of the cohort
- The mortality of the background population at 30 and 90 Days will be analyzed
- Validation of the Surgical Outcome Risk Tool in the study cohort and in the background population are planned
Detailed description
This is a multicenter, prospective, observational study. Length of patient recruitment is 12 weeks, the length of observation is 360 postoperative days. The expected number of patients is 1000.
Patients will be selected from the operation planning software on each study site. It is done by daily screening of the operation list and will be enrolled by applying the inclusion criteria. The criteria of surgical severity will be assessed by the UK surgical severity grading system ( AXA PPP/ Specialist Procedure Codes, United Kingdom). For that purpose a scroll list will be used, which is available on the website of the Surgical Outcome Risk Tool calculator.
Patient characteristics will be prospectively collected from medical records: age, gender, co-morbidities, medical history, physical activity, blood pressure, heart rate, oxygen saturation and neurological function; routine laboratory findings; type, complexity, urgency of surgery, incision localization and malignancy; lowest intraoperative systolic blood pressure, heart rate. The outcomes are the postoperative morbidity (assessed by the Postoperative Morbidity Survey) classified by the Clavien-Dindo classification tool (during hospital stay), and mortality, use of medications, hospital re-admissions (0-360 days) and new occurrence in different disease related national quality registries.Relationships between postoperative morbidity (POMS) the severity of morbidity (Clavien Dindo) and mortality will be analyzed. For illustration, Kaplan Meyer plots will be used, and for analyses Cox proportional hazard model will be used with adjustment for sex and age.
Additional changes:
- The length of observation for survival was extended to 3 years. The mortality at 3 years will be analyzed addressing the relationship between the postoperative morbidity (POMS) and mortality. Cox regression model will be used with adjustment of age, comorbidity and malignancy.
- Validation of Surgical Outcome Risk Tool is planned in two populations related to the PROFS study: eligible and background population. As the PROFS cohort was manually selected, we presumed that the eligible population is larger than the enrolled population.To enable electronic selection of the eligible population, we have developed a script, which translates the Swedish surgical codes into the UK severity codes. Using the same script we will classify the surgical severity in the background population of the PROFS cohort. Variables included in the Surgical Outcome Risk Tool will be extracted from the operation databases of each study site. The date of death will be extracted from the Swedish National Adress Registry and the malignancy from the registry of National Swedish Cancer Registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major surgical procedures | – | Procedure: Major surgical procedureAll patients selected to follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients who are operated for major surgical procedures during the study period in tertiary hospitals in Sweden.
Key inclusion criteria (13 listed)
- individuals classified by the American Society of Anesthesiologists Physical Status Classification System (ASA) ≥ 3 AND
- are scheduled for elective or emergency surgical procedure classified as -major OR major/complex by Surgical Outcome Risk Tool (SORT)
- organ transplantation
- immediate trauma
- breast
Key exclusion criteria (2 listed)
- patients who refuse the follow up
- patients who are not available for the follow up (living in other countries)
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 |
|---|---|---|
| Major surgical procedureobservation of postoperative outcomes | Procedure or surgery | Major surgical procedures |
Primary outcome
postoperative complications
Time frame: 3-10 postoperative days
postoperative morbidity survey, Clavien Dindo
1 secondary outcome
postoperative mortality
Time frame: 30-360 postoperative days and 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
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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.
Sigriduar Kalman, MD PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Procedure, Unspecified and Postoperative Complications, 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 13 inclusion and 2 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: finished, as of the sponsor's last update on 22 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative complications (time frame: 3-10 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2021.