STARSurg, Tripartite Colorectal Conference, July 2014
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Tripartite is an international colorectal meeting of surgeons from across Europe, Australasia and the Americas. Here we presented the colorectal-specific findings of STARSurg's first national collaborative cohort study, assesing the safety profile of NSAIDs in colorectal resection.
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STARSurg, Tripartite Colorectal Conference, July 2014
- 1. Multicentre, propensity-matched, cohort study assessing early post-operative NSAIDs and adverse events following colorectal surgery James Glasbey on behalf of the STARSurg Collaborative Final Year Medical Student, Cardiff University
- 2. 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)
- 3. • Prospective, multicentre observational cohort study • Delivered by a student-driven research collaboration with a dedicated study protocol Study Design
- 4. 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
- 5. Clavien Dindo I – 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 MinorMajor
- 6. Methods • Power calculation (80%, n = 900) • Propensity-score matching • Multivariate binary logistic regression - odds ratios (OR) & 95% C.I. • Data validation
- 7. Hypothesis Early post-operative NSAID administration is associated with increased operation-specific complications
- 8. Results • 1513 patients from 110 centres across the UK • Mean age 64.7y (95% CI 63.9-65.5) • 35% were ASA III-V
- 9. Results • 1172 colorectal resections (76%) • 74% elective, 26% emergency • 41% laparoscopic, 59% open • 26% permanent –ostomy, 22% temporary -ostomy
- 10. Results • During D1-3 post-operatively, 19% patients received an NSAID • Majority of NSAIDs prescribed were ibuprofen preparations (70%)
- 11. Results • Complications occurred in 62% of patients, which were major in 17% and minor in 45% • Anastomotic leak rate was 4.9%
- 12. Results
- 13. 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
- 14. 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
Hinweis der Redaktion
- Good morning, my name is James Glasbey and I’m presenting on behalf of the STARSurg Collaborative. My talk is on our first project, titled; Multi-centre, propensity-match, cohort study assessing early post operative NSAIDs and adverse events following GI surgery.
- As a background, the ideal analgesic regime following GI surgery has not yet been determined. NSAIDS are used routinely as part of ERAS and the lower echelons WHO pain ladder. As Professor Lobo alluded to in his intestinal failure lecture yesterday hey have the advantage of being opiate sparing, enhancing return of bowel function and therefore expediting recovery. However, literature shows NSAIDs being associated with increased complications, including anastomotic leak.
- The study design was a prospective, multicentre observation cohort study This project was delivered by the student-led research group starsurg, which recruited 253 medical students and junior doctors from 31 UK medical school across the UK with consultant oversight, with local investigators responsible for approving the study with governance offices and ensuirng data quality
- Inclusion criteria for this study was all consecutive elective and emergency GI resections over a 2 week during september and october 2013 Our primary outcome was a 30 day Clavien-Dindo complication rate.
- Briefly … I – antipyretics, duiretics, electrolytes We developed an online teaching module to familarise collaborators with this measure.
- The primary endpoint was powered to 80% to detect a 10% increase in clavien-dindo complicate rate, which required us to recruit 900 patients. The data was propensity matched to risk adjust to ASA grades and a revised cardiac risk index We then used a multivariate binary logistic regression model to generate odds ratios with bootstrapped 95% CI Finally, we prospectively-considered external data validation, with independent assessors recollecting 5% of data points to assess accuracy
- As was seen with Kleins 2012 paper0
- 76% of the resections were colorectal
- In terms of anti-inflammatory prescribing, 18.9% of patients where prescribed early NSAIDs, which was more likely for those patients on an ERAS programme The majority were prescribed ibuprofen
- 62% of patients had complications, which were major in 17% and minor in 45% Anastomotic leak rate of 4.9% comparable to a dutch cohort published in the BJS this year
- So to our regression model Regarding the effects of any dose NSAIDs, they were counterintuitvely associated with a reduction of all complications. This was scene more prominently in the high-dose NSAID compared to low dose And was seen in minor complications but not major (IV & V)
- Selection bias as more well patients may have put onto ERAS programmes and avoided opioid therpies The improved odds ratios remaining despite risk-adjustment And data points were validated to a high degree of accuracy
- This leaves me with 3 key messages: Early NSAID use was associated with a reduction in post-operative adverse events following GI resection, indicating a beneficial anti-inflammatory effect – note in terms of NSAIDs were are predominantly talking about ibuprofen, which in fact was also demonstrated to be safe in kleins BMJ paper also. This has relevance to future perioperative analgesic prescribing and we think justifies further exploration No evident increase in anastomotic leak with early NSAID use and although this is probably underpowered, ibuprofen is probably safe in low to mdeium risk patients, perhaps even high risk if given as one off or short course 3. The student-led, collaborative model can rapidly deliver high-quality multicentre dataset and we are excited to expand this over coming years.