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NCT Number: NCT03382054

Frailty and Post-operative Complications in Older Surgical Patients: The Implication of Frailty and Preoperative Risk Assessment

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative complications

    Time frame: 06/2016-12/2022

    ICD-10 coded diagnoses for the hospitalization

Secondary outcomes

  1. Duration of Hospital stay

    Time frame: 06/2016-12/2022

  2. Duration of Intensive Care Unit Stay

    Time frame: 06/2016-12/2022

  3. Procedures

    Time frame: 06/2016-12/2022

    The procedures are measured regarding the following practices: anesthesiological, surgical, physiotherapeutic, social, cognitive, therapeutic, behavioral

  4. Morbidity

    Time frame: 06/2016-12/2022

  5. Ventilation

    Time frame: 06/2016-12/2022

    Ventilation is measured in hours.

  6. Requirements for intensive care unit

    Time frame: 06/2016-12/2022

  7. Intensive care unit scores

    Time frame: 06/2016-12/2022

  8. Disease severity

    Time frame: 06/2016-12/2022

  9. Postoperative Delirium

    Time frame: 06/2016-12/2022

    Delirium is measured with validated delirium scores.

  10. Mortality

    Time frame: 06/2016-12/2022

    Mortality is measured in hospital.

  11. Medical costs

    Time frame: 06/2016-12/2022

    Costs incurred during hospitalization

  12. Physiotherapy

    Time frame: 06/2016-12/2022

    Physiotherapy is measured by Physiotherapists support.

  13. Nutritional therapy 1

    Time frame: 06/2016-12/2022

    Nutritional consultations

  14. Nutritional therapy 2

    Time frame: 06/2016-12/2022

    Feeding

  15. Post - intensive care syndrome

    Time frame: 06/2016-12/2022

    Post - Intensive care syndrome is measured by a cluster of symptoms that are unique to the Intensive care unit environment.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Frailty and Post-operative Complications in Older Surgical Patients: The Implication of Frailty and Preoperative Risk Assessment - A Retrospective Analysis

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Dec 22, 2017
Registry last updated
Jun 15, 2023

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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