midas from observation to trial aneel bhangu clinical lecturer in surgery university of birmingham,...
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MIDASFrom Observation to Trial
Aneel BhanguClinical Lecturer in Surgery
University of Birmingham, UK
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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
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Cohort studies
• New brand– Risk adjustment – Data governance support– Funding
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Surgical site infection
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Story
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N=2756 colorectal resection
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STARSurg is born!
• Findings relevant to the UK• Start of STARSurg• “elevated ambition”• Linked national network• Every UK medical school– 109 hospitals
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MIDAS is born!
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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.
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Problem child• 18 months to
develop• Difficult trial –
assessing pain• Big, broad team –
acute pain experts• Safety – multiple
domains• Stage I NIHR funding
application
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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?