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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382054
• Other study ID #: FrailAmb II
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Older Patients
• Postoperative Complications
• Surgery

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	ICD-10 coded diagnoses for the hospitalization	06/2016-12/2022
Secondary	Duration of Hospital stay		06/2016-12/2022
Secondary	Duration of Intensive Care Unit Stay		06/2016-12/2022
Secondary	Procedures	The procedures are measured regarding the following practices: anesthesiological, surgical, physiotherapeutic, social, cognitive, therapeutic, behavioral	06/2016-12/2022
Secondary	Morbidity		06/2016-12/2022
Secondary	Ventilation	Ventilation is measured in hours.	06/2016-12/2022
Secondary	Requirements for intensive care unit		06/2016-12/2022
Secondary	Intensive care unit scores		06/2016-12/2022
Secondary	Disease severity		06/2016-12/2022
Secondary	Postoperative Delirium	Delirium is measured with validated delirium scores.	06/2016-12/2022
Secondary	Mortality	Mortality is measured in hospital.	06/2016-12/2022
Secondary	Medical costs	Costs incurred during hospitalization	06/2016-12/2022
Secondary	Physiotherapy	Physiotherapy is measured by Physiotherapists support.	06/2016-12/2022
Secondary	Nutritional therapy 1	Nutritional consultations	06/2016-12/2022
Secondary	Nutritional therapy 2	Feeding	06/2016-12/2022
Secondary	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