RAINBOW A comparative study of surgery for inflammatory bowel disease Ruth Blanco Colino, Tom Drake, Laura Gavagna, Camilla Kjeldsen, Samuel Lee
Why? Inflammatory Bowel Disease is common Outcomes Young patients Non-cancer research priority
Strengths Defined, relatively low volume, population allows focussed data collection Common Condition Easily understood by students Wide scope for future studies and involving students in European trials
Aims To conduct a multicentre, high-quality prospective cohort study of surgical management for IBD across Europe To determine risk-adjusted 30-day and 12-month outcomes of surgery for IBD
RAINBOW Patient Care Hypothesis Generation Clinical Evidence Education Trials Data Access Students into trials Incorporating students and early career doctors into trials Collaboration as a resource
Population All patients undergoing resection for ulcerative colitis or Crohn’s disease
Primary Outcome 30 days + 12 months 30 days + 12 months Follow-up… Primary Outcome Overall complication rate Adjusted for variables prior to index event of operation
Secondary Outcomes 30 days + 12 months 30 days + 12 months Follow-up… Secondary Outcomes Specific Complications: -Venous Thromboembolism -Infectious complications -Anastomotic leakage -Stoma complications Pathological quality of resection Disease Recurrence Length of stay Reoperation Readmission
IBD disease activity Role of perioperative biologic therapy Prognostic Blood Tests Faecal Calprotectin Perioperative nutrition Surgical technique & emergency Proposed Outputs
Scope for ‘plug-in’ studies Quality of Life Outcomes -IBDQ-9 -EQ-5D Patient Reported Outcome Measures Psychological repercussions -Body image -Depression
Summary FUTU RE TRIA LS EASY TO CONTR OL RESEARC H PRIORIT Y LOTS OF PATIEN TS
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