MIDASFrom Observation to Trial

Aneel BhanguClinical 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?