Timing Of Nutrition In emergenCy laparotomy (TONIC) – A randomised trial comparing early parenteral nutrition vs standard nutritional care in adults undergoing emergency laparotomy
Hospital complications in adults undergoing emergency laparotomy
Early PN through central venous catheter (CVC) or PICC, commencing within 48 hours of emergency laparotomy/laparoscopy, with biochemistry monitoring as per NICE Clinical Guideline 32. PN is prescribed on a 24-hour basis and would continue until the participant has recovered gastrointestinal function, sufficient to allow adequate enteral intake. This is determined by the nutrition team in collaboration with the surgical team. Standard nutritional care, which may include no support, oral nutritional supplements or nasoenteric feeding at anytime point. Clinicians can use PN in the control group, but, as per NICE guidance, not before 5 days post-surgery unless there is pressing clinical need. Participants will be followed up at discharge, 30 days and 90 days post operation. Randomisation will be provided by BCTU using a secure online Electronic Data Capture (EDC) system (available at https://bctu-redcap.bham.ac.uk/). After eligibility has been confirmed and informed consent (or declaration for those who cannot provide informed consent) has been received, the participant can be randomised into the trial using the online EDC system. A worksheet replicating the electronic randomisation form and the eligibility and consent form may be used to collate the necessary information prior to randomisation. All questions and data items on the online Randomisation Form and the eligibility and consent form must be answered prior to a potential participant being randomised into the trial and a Trial Number being issued. Participants will be randomised at the level of the individual in a 1:1 ratio to either early administration of PN or standard care via a central secure web-based randomisation system available 24 hours/day at the BCTU. A minimisation algorithm will be used within the randomisation system to ensure balance in the intervention allocations over the following variables: NELA risk (<5 OR ≥5%) [33] Nutrition Risk Score (<3 OR ≥3) [34] Recruiting site (hospital name).
1. Aged ≥18 years 2. Scheduled for NELA eligible expedited, urgent or immediate emergency laparotomy or laparoscopy according to National Confidential Enquiry into Patient Outcome and Death (NCEPOD) criteria 3. Able to give informed consent, with interpreters where necessary OR personal consultee/legal representative provides assent/consent if a patient temporarily lacks capacity
1. Undergoing trauma-related laparotomy or laparoscopy 2. Being treated with palliative/end of life intent 3. Abdominal surgery in the preceding 30 days 4. On long term PN prior to admission