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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT03382054
Collaborator
(none)
30,000
Enrollment
1
Location
139
Anticipated Duration (Months)
215.9
Patients Per Site Per Month

Study Details

Study Description

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 65 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Frailty and Post-operative Complications in Older Surgical Patients: The Implication of Frailty and Preoperative Risk Assessment - A Retrospective Analysis
    Actual Study Start Date :
    Jun 1, 2016
    Anticipated Primary Completion Date :
    Dec 31, 2027
    Anticipated Study Completion Date :
    Dec 31, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    Older surgical patients

    Male and female patients with age 65 years and above scheduled for surgery

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative complications [06/2016-12/2027]

      ICD-10 coded diagnoses for the hospitalization

    Secondary Outcome Measures

    1. Duration of Hospital stay [06/2016-12/2027]

    2. Duration of Intensive Care Unit Stay [06/2016-12/2027]

    3. Procedures [06/2016-12/2027]

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

    4. Morbidity [06/2016-12/2027]

    5. Postoperative Delirium [06/2016-12/2027]

    6. Mortality [06/2016-12/2027]

    7. Medical costs [06/2016-12/2027]

      Costs incurred during hospitalization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Male and female patients with age 65 years and above scheduled for surgery in the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité
    • Universitätsmedizin Berlin

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin Berlin Germany 13353

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Claudia Spies, Clinical director of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT03382054
    Other Study ID Numbers:
    • FrailAmb
    First Posted:
    Dec 22, 2017
    Last Update Posted:
    Nov 26, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Frailty
    Postoperative Complications

    Study Results

    No Results Posted as of Nov 26, 2019