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Restrictive strategy vs usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): A multicentre, randomised, parallel-arm, non-inferiority trial

The Lancet Jun 14, 2019

van Dijk AH, et al. - Via a multicentre, randomised, parallel-arm, non-inferiority study in 24 academic and non-academic hospitals on 1,067 patients aged between 18–95 years, the researchers intended to understand the comparison among the non-inferiority of a restrictive strategy and a step wise selection with usual care to determine (in)efficient use of cholecystectomy. For the restrictive strategy, cholecystectomy was advised for patients who would fulfill the five pre-specified criteria of the triage instrument i.e, severe pain attacks, pain lasting 15–30 min or longer, pain located in epigastrium or right upper quadrant, pain radiating to the back, and a positive pain response to simple analgesics. In patients with gallstones and abdominal pain, sub-optimal reduction of pain was concluded with both usual care and following a restrictive strategy for selection for cholecystectomy. However, fewer cholecystectomies were associated with the restrictive strategy.
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