MIDAS From Observation to Trial Aneel Bhangu Clinical Lecturer in Surgery University of Birmingham, UK

Cohort studies New brand of audit->research – Lessons learned from UK national appendicectomy audit 2012 – High quality = protocol driven, reproducible – Short, snapshot = deliverable, engaging and meaningful -> large numbers – National/international – Build networks

Cohort studies New brand – Risk adjustment – Data governance support – Funding

Surgical site infection

Story

N=2756 colorectal resection

STARSurg is born! Findings relevant to the UK Start of STARSurg “elevated ambition” Linked national network Every UK medical school – 109 hospitals

MIDAS is born!

Trial Summary P – patients undergoing surgery resulting in anastomosis of stoma. N=1600 I – 400mg ibuprofen TDS for 5 days (including after discharge) C – identical placebo. Both receive 15mg lansoprazole. Stratify for epidural use. Allow epidural, PCA, oral analgesia. Tests addition to a flexible regime. O – co-primary – PATIENT – patient reported pain on deep coughing or movement, TDS on 11 point VAS. – CLINICIAN – Acute Kidney Injury – KDIGO II- measured on serum creatinine – SECONDARY – pain failure, leak, GI bleed, overall complications, opiate intake, costs, duration epidural/PCA.

Problem child 18 months to develop Difficult trial – assessing pain Big, broad team – acute pain experts Safety – multiple domains Stage I NIHR funding application

Delivery 20 centres, 3.5 years Disseminated via STARSurg Delivered by joint trainee collaboratives Students from GRANULE embedded to recruit and deliver Moves STARSurg into a perioperative research collaborative – European brand?