Multicentre observational cohort study of NSAIDs as risk factors for postoperative adverse events in gastrointestinal surgery

BMJ Open. 2014 Jun 27;4(6):e005164. doi: 10.1136/bmjopen-2014-005164.

Abstract

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.

Keywords: Surgery.

Publication types

  • Multicenter Study
  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Cohort Studies
  • Digestive System Surgical Procedures*
  • Female
  • Humans
  • Male
  • Postoperative Complications / chemically induced*
  • Postoperative Complications / epidemiology*
  • Prospective Studies
  • Research Design
  • Risk Factors

Substances

  • Anti-Inflammatory Agents, Non-Steroidal