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

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

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.

Study Overview

• Status: Completed
• Conditions: Frailty; Surgery; Older 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.

• Study Type: Observational
• Enrollment (Actual): 25000

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Male and female patients with age 70 years and above scheduled for surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Older robust surgical patients; Male and female patients with age 65 years and above scheduled for surgery, which are robust according to Fried's Modified Frailty Score.
Older pre-frail surgical patients; Male and female patients with age 65 years and above scheduled for surgery, which are pre-frail according to Fried's Modified Frailty Score.
Older frail surgical patients; Male and female patients with age 65 years and above scheduled for surgery, which are frail according to Fried's Modified Frailty Score.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	ICD-10 coded diagnoses for the hospitalization	06/2016-12/2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Hospital stay		06/2016-12/2022
Duration of Intensive Care Unit Stay		06/2016-12/2022
Procedures	The procedures are measured regarding the following practices: anesthesiological, surgical, physiotherapeutic, social, cognitive, therapeutic, behavioral	06/2016-12/2022
Morbidity		06/2016-12/2022
Ventilation	Ventilation is measured in hours.	06/2016-12/2022
Requirements for intensive care unit		06/2016-12/2022
Intensive care unit scores		06/2016-12/2022
Disease severity		06/2016-12/2022
Postoperative Delirium	Delirium is measured with validated delirium scores.	06/2016-12/2022
Mortality	Mortality is measured in hospital.	06/2016-12/2022
Medical costs	Costs incurred during hospitalization	06/2016-12/2022
Physiotherapy	Physiotherapy is measured by Physiotherapists support.	06/2016-12/2022
Nutritional therapy 1	Nutritional consultations	06/2016-12/2022
Nutritional therapy 2	Feeding	06/2016-12/2022
Post - intensive care syndrome	Post - Intensive care syndrome is measured by a cluster of symptoms that are unique to the Intensive care unit environment.	06/2016-12/2022

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty; Postoperative Complications
• Other Study ID Numbers: FrailAmb II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No