Abstract

Abstract Background The Whipples is an operation associated with major morbidity. Common risks include infection, wound problems and delayed gastric emptying. Less common but significant complications include fistula, anastomotic leak and cardiorespiratory dysfunction. This often requires intensive care or further procedures. Overall, mortality is 3%. This wide array of possible post-operative outcomes must be documented accurately on a consent form. However, what is stated often varies significantly depending on the consenting clinician. We assess the effect of a transition to an entirely electronic patient record (EPR) system on the consent process and the subsequent impact of standardised electronic consent forms. Methods Comparison of documented risks and additional procedures against ideal consent adapted from a patient information leaflet for Whipples. Cases performed by a tertiary centre hepatobiliary surgery department. Paper consent forms from July to September 2022 compared to electronically signed consent forms obtained from the EPR system from September to November 2022. Intervention in December 2022 (automated consent form). Re-audit from December 2022 to January 2023. Descriptive statistical analysis. Results 25 consent forms assessed. Majority of forms completed by middle grades (92%). Eighteen documented risks and four additional procedures in ideal consent. Complications such as bleeding, infection and cardiorespiratory complications consistently feature in consent forms. Transition to electronic system meant most additional procedures documented less frequently, as are other complications such as visceral injury. Broad improvements in consenting documentation following intervention. Conclusions Introduction of pre-filled consent forms produced swift and significant improvements in consistency of consent forms. Further assessment of other index procedures of hepatobiliary, general and vascular surgery to follow.

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