Improvement of Perioperative Care of Elderly Patients

Not Applicable

Completed

• Conditions: Perioperative Care

• Registration Number: NCT03325413
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

The focus of this study is the development of a perioperative treatment concept for elderly patients, based on individual necessities and risk factors, aiming to improve patient outcome. The planned interventions include preoperative screening for malnutrition, frailty and uncalled-for long-term medication, if required followed by early prophylaxis and treatment of these risk factors, prior to or during surgery.

Detailed Description

In Germany every second inpatient surgical intervention is performed on patients aged 60 years and above. These patients often offer an extensive set of risk factors such as frailty, malnutrition, poor physical fitness and multi-morbidity that may in turn lead to longer hospitalizations and decline of health and functional status after surgery. An age-related increase in postoperative complications, such as postoperative cognitive dysfunction (POCD) and delirium is associated with a higher rate of postoperative morbidity, mortality and longer hospitalization.

Early detection of risk factors and implementation of prophylactic measures is important to reduce postoperative complications and improve clinical outcomes in elderly patients. The aim of our study is to develop and verify a protocol - which allows for a systematic evaluation of risk factors and the implementation of prophylactic or therapeutic measures in order to optimize the postoperative outcome. The feasibility of our protocol will be verified in clinical practice by systematic process evaluations.

Study Timeline

• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-30
• Study Start: 2017-11-01
• Primary Completion: 2020-05-14
• Study Completion: 2020-05-14
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-15
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• Age >64 years
• Written informed patients consent
• forthcoming elective surgery
• Time interval from inclusion to appointed surgery at least 5 days

Exclusion Criteria

• Refusal of consent
• Illiteracy
• Poor knowledge ofGerman language
• Mental disability
• Vision handicap (not corrected)
• Hearing handicap (not corrected)
• Benzodiazepine abuse
• Drug/ substance abuse
• Psychosis
• Parkinson disease
• Emergency surgery
• Planned postoperative ICU treatment
• Planned inpatient stay 1 night
• Cerebral surgery
• Ophthalmological surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Functional abilities	Evaluation preoperatively, 1 month, 6 months after surgery	Change in functional abilities from baseline, evaluated by Instrumental Activities of Daily Living (IADL) score

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	Evaluation evaluation of complications at 2-5 days, 1 month, 6 months after surgery	Incidence of postoperative complications
Cognitive impairment	Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery	DemTect: cognitive screening instrument, sensitive to the early symptoms of dementia
Attention and task switching	Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery	The Trail Making Test A\&B (TMT A\&B): a neuropsychological test of visual attention and task alternation
Health related quality of life	Evaluation preoperatively, 1 month, 6 months after surgery	Measured by a 12-item short-form (SF-12) Health Survey
Attentional capabilities	Evaluation preoperatively, at 2-5 days, 1 month, 6 months after surgery	TAP Alertness: a computerized, standardized neuropsychological test for attentional performance.
Hospital length of stay	1 month	Day of admission until day of discharge

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf (UKE); 🇩🇪 Hamburg, Germany