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

Completed

• Conditions: Older Patients; Surgery; Frailty

• Registration Number: NCT03382054
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-22
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative complications	06/2016-12/2022	ICD-10 coded diagnoses for the hospitalization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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