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

NCT03382054 | Completed

• 1 other identifier: FrailAmb II
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Surgery; Older Patients

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  ICD-10 coded diagnoses for the hospitalization

  06/2016-12/2022

Secondary Outcomes (15)

• Duration of Hospital stay

  06/2016-12/2022

• Duration of Intensive Care Unit Stay

  06/2016-12/2022

• Procedures

  06/2016-12/2022

• Morbidity

  06/2016-12/2022

• Ventilation

  06/2016-12/2022

Study Arms (3)

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.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical director of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK)

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 22, 2017
• Study Start: June 1, 2016
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)