STARSurg, Tripartite Colorectal Conference, July 2014
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Transcript of STARSurg, Tripartite Colorectal Conference, July 2014
Multicentre, propensity-matched, cohort study assessing early post-
operative NSAIDs and adverse events following colorectal surgery
James Glasbey
on behalf of the STARSurg CollaborativeFinal Year Medical Student, Cardiff University
Background• Optimal analgesic regime post-GI surgery has not yet been determined
• NSAIDs are used as part of ERAS & WHO pain ladder
• NSAIDs have been associated with increased operation-specific complications, including anastomotic leak (Klein M, BMJ, 2012;345:e6166)
• Prospective, multicentre observational cohort study
• Delivered by a student-driven research collaboration with a dedicated study protocol
Study Design
Methods
• Inclusion: Adults, consecutive elective or emergency, partial or complete gastrointestinal resections over a 2-week period
(September – October 2013)
• Primary outcome: 30-day Clavien-Dindo complication rate
Clavien DindoI – deviation from standard post-op course within ‘allowed therapeutic regimes’
II – complication req. pharmacological intervention
III – complication req. surgical, endoscopic or radiological intervention
IV – complication req. ICU admission
V – death
Min
or
Majo
r
Methods
• Power calculation (80%, n = 900)
• Propensity-score matching
• Multivariate binary logistic regression - odds ratios (OR) & 95% C.I.
• Data validation
Hypothesis
Early post-operative NSAID administration is associated with increased operation-specific
complications
Results
• 1513 patients from 110 centres across the UK
• Mean age 64.7y (95% CI 63.9-65.5)
• 35% were ASA III-V
Results• 1172 colorectal resections (76%)
• 74% elective, 26% emergency
• 41% laparoscopic, 59% open
• 26% permanent –ostomy, 22% temporary -ostomy
Results
• During D1-3 post-operatively, 19% patients received an NSAID
• Majority of NSAIDs prescribed were ibuprofen preparations (70%)
Results
• Complications occurred in 62% of patients, which were major in 17% and minor in 45%
• Anastomotic leak rate was 4.9%
Results
Limitations• Narrow time window for data collection• Risk of selection bias
• Large, pragmatic real-world population with high external validity
• Risk-adjusted• 98% accuracy in validated data points
Key Messages• Early NSAID use was associated with reduction in total complications following colorectal resection
• No evident increase in anastomotic leak (underpowered)
• The student-led, collaborative model can rapidly deliver high-quality, multi-centre datasets