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

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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

www.starsurg.org

jamesglasbey@gmail.com

Questions?