The TONIC study
About the study
The TONIC study will help us to work out whether we need to provide earlier nutrition care to people having major emergency operations, and if the costs of this support its use in the NHS.
Aim of the study
Management of nutrition is highly variable in the emergency setting.
No high quality definitive randomised trial has assessed the impact of early nutrition in a purely emergency general surgery population.
The TONIC study aims to assess the impact of early parenteral nutrition (PN) on complication frequency and severity following emergency laparotomy.
Study Team
Mr Matthew Lee
Chief Investigator
Birmingham Health Partners (BHP) Clinician Scientist & Honorary Consultant Colorectal Surgeon
Ms Sue Blackwell
Patient and Public Involvement Co-applicant
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Mrs Manjinder Kaur
Trials Management Team Leader
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Current enrolment curve
Recruitment target:
Information about the study
Things to Know
This study will help us to work out whether we need to provide earlier nutrition care to people having major emergency operations, and if the costs of this support its use in the NHS.
Participant Population
Adult patients undergoing any National Emergency Laparotomy Audit (NELA) eligible procedure. No abdominal surgery in preceding 30 days.
Study Funders
The study is funded by the National Institute of Health and Care Research (NIHR). The sponsor is the University of Birmingham.
Treatments
Early parenteral nutrition (PN) within 48 hours of surgery, or 'standard care' in line with NICE CG32 which recommends PN should be started when a patient has gone 5 days without eating and drinking normally.
Study Design
A multi-centre, two arm, parallel group, superiority, pragmatic randomised controlled clinical trial, with an internal pilot to assess feasibility and full economic evaluation to assess cost- effectiveness.
Primary Objective
To determine whether early PN in patients undergoing emergency laparotomy/laparoscopy reduces in hospital post-operative complications assessed at hospital discharge as compared to usual nutritional care.