Multicentre observational cohort study of NSAIDs as risk factors for postoperative adverse events in gastrointestinal surgery
| Autor: | Stephen J Chapman, Dimitri Nepogodiev, Chetan Khatri, James Glasbey, Michael Kelly, J Edward Fitzgerald, Aneel Bhangu |
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| Rok vydání: | 2014 |
| Předmět: |
Male
Clinical audit medicine.medical_specialty Pathology Evidence-based practice Anastomosis Cohort Studies Postoperative Complications Risk Factors Protocol Clinical endpoint Humans Medicine Prospective Studies Adverse effect Digestive System Surgical Procedures Research ethics business.industry Anti-Inflammatory Agents Non-Steroidal General Medicine Research Design Emergency medicine Female Surgery business Complication Cohort study |
| Zdroj: | BMJ Open |
| ISSN: | 2044-6055 |
| Popis: | Introduction: Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as postoperative analgesia by the Enhanced Recovery After Surgery Society. Recent studies have raised concerns that NSAID administration following colorectal anastomosis may be associated with increased risk of anastomotic leak. This multicentre study aims to determine NSAIDs’ safety profile following gastrointestinal resection. Methods and analysis: This prospective, multicentre cohort study will be performed over a 2-week period utilising a collaborative methodology. Consecutive adults undergoing open or laparoscopic, elective or emergency gastrointestinal resection will be included. The primary end point will be the 30-day morbidity, assessed using the Clavien-Dindo classification. This study will be disseminated through medical student networks, with an anticipated recruitment of at least 900 patients. The study will be powered to detect a 10% increase in complication rates with NSAID use. Ethics and dissemination: Following the Research Ethics Committee Chairperson's review, a formal waiver was received. This study will be registered as a clinical audit or service evaluation at each participating hospital. Dissemination will take place through previously described novel research collaborative networks. |
| Databáze: | OpenAIRE |
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