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Clinical Trial
. 2019 Mar 20;19(1):87.
doi: 10.1186/s12877-019-1101-7.

A multicomponent prehabilitation pathway to reduce the incidence of delirium in elderly patients in need of major abdominal surgery: study protocol for a before-and-after study

Affiliations
Clinical Trial

A multicomponent prehabilitation pathway to reduce the incidence of delirium in elderly patients in need of major abdominal surgery: study protocol for a before-and-after study

Ties L Janssen et al. BMC Geriatr. .

Abstract

Background: Due to the increase in elderly patients who undergo major abdominal surgery there is a subsequent increase in postoperative complications, prolonged hospital stays, health-care costs and mortality rates. Delirium is a frequent and severe complication in the 'frail' elderly patient. Different preoperative approaches have been suggested to decrease incidence of delirium by improving patients' baseline health. Studies implementing these approaches are often heterogeneous, have a small sample and do not provide high-quality or successful strategies. The aim of this study is to prevent postoperative delirium and other complications by implementing a unique multicomponent and multidisciplinary prehabilitation program.

Methods: This is a single-center controlled before-and-after study. Patients aged ≥70 years in need of surgery for colorectal cancer or an abdominal aortic aneurysm are considered eligible. Baseline characteristics (such as factors of frailty, physical condition and nutritional state) are collected prospectively. During 5 weeks prior to surgery, patients will follow a prehabilitation program to optimize overall health, which includes home-based exercises, dietary advice and intravenous iron infusion in case of anaemia. In case of frailty, a geriatrician will perform a comprehensive geriatric assessment and provide additional preoperative interventions when deemed necessary. The primary outcome is incidence of delirium. Secondary outcomes are length of hospital stay, complication rate, institutionalization, 30-day, 6- and 12-month mortality, mental health and quality of life. Results will be compared to a retrospective control group, meeting the same inclusion and exclusion criteria, operated on between January 2013 and October 2015. Inclusion of the prehabilitation cohort started in November 2015; data collection is ongoing.

Discussion: This is the first study to investigate the effect of prehabilitation on postoperative delirium. The aim is to provide evidence, based on a large sample size, for a standardized multicomponent strategy to improve patients' preoperative physical and nutritional status in order to prevent postoperative delirium and other complications. A multimodal intervention was implemented, combining physical, nutritional, mental and hematinic optimization. This research involves a large cohort, including patients most at risk for postoperative adverse outcomes.

Trial registration: The protocol is retrospectively registered at the Netherlands National Trial Register (NTR) number: NTR5932 . Date of registration: 05-04-2016.

Keywords: Abdominal aortic aneurysm; Colorectal surgery; Delirium; Geriatric patient; Multicomponent; Prehabilitation; Prevention; Quality of life.

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Conflict of interest statement

Ethics approval and consent to participate

The Medical Ethical Research Committee of Rotterdam, Maasstad Hospital (TWOR) approved the research protocol, ID number NL55694.101.15, in June 2016. Additionally, the Local Research and Development Committee at the Amphia Hospital approved the protocol (Local ID number 1473.16). Serious adverse events and protocol amendments will be reported to this medical ethical committee. Written informed consent will be obtained from all study participants during the first outpatient clinic visit.

Consent for publication

Not applicable.

Competing interests

The PhD program of the corresponding author (T.L. Janssen) is funded by an ‘unrestricted grant’ by Amphia Fund for innovation. All other authors declare that they have no competing interests.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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