Clinical trial NCT03382054: Frailty and Post-operative Complications in Older Surgical Patients: The Implication of Frailty and Preoperative Risk Assessment
Official title: Frailty and Post-operative Complications in Older Surgical Patients: The Implication of Frailty and Preoperative Risk Assessment - A Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Surgery
Older Patients
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 25000
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients with age 70 years and above scheduled for surgery

Brief summary: Frailty is prevalent in older adults and may be a better predictor of post-operative morbidity and mortality than chronological age. Preoperative risk factors and physiological reserves were assessed on patients more than 70 years old who are scheduled for surgery under general or regional anesthesia. The aim of this retrospective analysis was to examine the impact of relevant geriatric assessments on adverse outcomes in older surgical patients.

Detailed description: The goal of this study is to analyze the effect of frailty status on postoperative outcomes. These include postoperative complications (only ICD-10 coded diagnoses), length of hospitalization (ward/ICU), disposition, and survival. The project will also attempt to find synergism between a positive frailty status and common medical conditions (e.g. diabetes, congestive heart failure, coronary artery disease, dementia, and kidney disease), as well as anesthesiological and surgical processes (e.g. duration and type of anesthesia, surgical risk, and surgical discipline). Different assessment tools will be analyzed regarding their predictive power and clinical practicability. This should help improve preoperative risk assessment and allow for the multidimensional (physical, cognitive, social) identification of relevant frailty characteristics in the perioperative setting. All outcome parameters, including admission and discharge periods, will be collected using coded information from our hospital database. There will be no follow-up measurements after hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Male and female patients with age 70 years and above scheduled for surgery in the Department of Anesthesiology and Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin

Primary outcomes:
measure: Postoperative complications
timeFrame: 06/2016-12/2022
Secondary outcomes:
measure: Duration of Hospital stay
timeFrame: 06/2016-12/2022
measure: Duration of Intensive Care Unit Stay
timeFrame: 06/2016-12/2022
measure: Procedures
timeFrame: 06/2016-12/2022
measure: Morbidity
timeFrame: 06/2016-12/2022
measure: Ventilation
timeFrame: 06/2016-12/2022
measure: Requirements for intensive care unit
timeFrame: 06/2016-12/2022
measure: Intensive care unit scores
timeFrame: 06/2016-12/2022
measure: Disease severity
timeFrame: 06/2016-12/2022
measure: Postoperative Delirium
timeFrame: 06/2016-12/2022
measure: Mortality
timeFrame: 06/2016-12/2022
measure: Medical costs
timeFrame: 06/2016-12/2022
measure: Physiotherapy
timeFrame: 06/2016-12/2022
measure: Nutritional therapy 1
timeFrame: 06/2016-12/2022
measure: Nutritional therapy 2
timeFrame: 06/2016-12/2022
measure: Post - intensive care syndrome
timeFrame: 06/2016-12/2022
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: