Protocol for a multi-centre observational and mixed methods pilot study to identify factors predictive of poor functional recovery after major gastrointestinal surgery and strategies to enhance uptake of peri-operative optimisation.

2021 
INTRODUCTION National datasets report large variations in outcomes from older people (≥65 years) between different UK surgical units. This implies that not all patients receive the same level of care or access to resources, such as rehabilitation or allied health professional input. This might impact functional decline. AIMS To evaluate the baseline status of older patients facing major gastrointestinal surgery and the impact of variation in perioperative assessment and provision of perioperative support on functional outcomes. Patients' experiences and views of assessment and optimisation will be explored via integrated qualitative semi-structured interviews. METHODS AND ANALYSIS Cohort study: This multi-centre, pilot cohort will include patients ≥65 years presenting via both elective and emergency pathways at 3-5 South Yorkshire NHS hospitals (Clinical Trials registration: NCT04545125). The primary outcome is functional recovery measured using the WHO Disability Assessment Schedule 2.0 at 6 weeks post-operation. Secondary outcomes include feasibility, quality of life, length of stay and complication rate. An opportunistic sample size of 120 has been estimated and will inform the design of a future, adequately powered study. Qualitative study: 20-30 semi-structured patient interviews will be undertaken with patients from the cohort study to explore experiences of assessment and optimisation. Interviews will be digitally recorded, transcribed verbatim and analysed according to the Framework approach. ETHICS AND DISSEMINATION This study has been approved by the NHS Research Ethics Committee and is registered centrally with HRA. It has been adopted by the NIHR Portfolio scheme. Dissemination will be via international and national surgical and geriatric conferences.
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