Karolinska Institutet
Stockholm, Sweden
Location status: Recruiting
NCT Number: NCT07603622
Over 300 million surgeries are performed globally every year. Complications after surgery - infections, cardiovascular conditions, postoperative pulmonary complications and renal impairment - affect survival and quality of life.
Age and co-morbidity are unmodifiable factors, contributing to increased risk of these perioperative complications. However, a modifiable risk factor is physical activity. This study aims to test if self reported physical activity has added predicted value, beyond established risk factors, for predicting perioperative morbidity and mortality.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Stockholm, Sweden
Location status: Recruiting
Research question: This cohort study investigates if higher levels of self reported physical activity at preoperative assessment has added predicted value, beyond established risk factors, for predicting perioperative morbidity and mortality.
Background: Previous studies of perioperative outcomes in high-income countries indicate that close to 20% had complications within 30 days after surgery, and that around 3% died within 1 yr after surgery. In multiple studies, postoperative complications massively increase risk of 1yr mortality. Whilst perioperative complications are under-reported, they affect length of stay and days at home up to 30 days after surgery (DAH30). DAH30 is a validated, patient-centered outcome measure with prognostic importance due to high sensitivity to changes in surgical risks and the impact of surgical complications. DAH365, the days at home up to one year after surgery, is also an important patient-centered outcome measure.
Data collection: Age, sex, body mass index, co-morbid conditions (using ICD-codes and reported medication) as well as American Society of Anesthesiologists (ASA) physical status classification will be recorded. The predictor of interest: the Metabolic Equivalent of Task Score (MET-score), reported in the electronic health record by the attending anesthesiologist based on patient history in conjunction with the preoperative assessment.
Analysis: The MET-score is the predictor of interest. The potential added predictive value of the MET-score, will be assed using a machine learning approach, by comparing it to other established predictive factors.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: [Time Frame: Mortality will be recorded at 30, 60, 90 and 365 days after index surgery]
Death within the time frames described below
Time frame: 30 days after index surgery
DAH30: Patients who are hospitalized for 14 days postoperatively but are alive on day 30 will have DAH30=16. Patients who are hospitalized for five days, then discharged, but return after 10 days for an additional 11-day stay, will have DAH30=14. Anyone who dies within 30 days will have DAH30=0. This outcome measure is validated in several studies and has a significant advantage in that it correlates well with complications, even better than length of stay (LOS).
Time frame: 365 days after index surgery
DAH365: See above
Contact information is provided by the study sponsor or research team.
Arman Valadkhani, MD, PhD
CONTACT
Max Bell, MD, PhD
CONTACT
Karolinska Institutet
Other
Acronym: PeriopPrePA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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