Research in context
Evidence before this study
International guidelines advise laparoscopic cholecystectomy as a treatment for uncomplicated symptomatic cholecystolithiasis. A systematic review published in 2013, two prospective studies published in 2011 and 2017, and the results of two randomised trials published in 2005 showed that 10–41% of all patients following cholecystectomy continued to have abdominal pain. Persistent postoperative pain is associated with a significant burden for health-care systems, especially from an economical viewpoint.
A systematic review of international guidelines published in 2017 showed no consensus on the criteria to select patients for elective cholecystectomy. The absence of consensus is further illustrated in studies showing large variation in clinical practice among and within countries. We found no studies or trials assessing different criteria for indication of cholecystectomy for uncomplicated symptomatic cholecystolithiasis, or studies assessing the effectiveness of a more restrictive strategy for selecting patients for cholecystectomy, compared with standard of care.
Added value of this study
Our randomised, controlled, non-inferiority trial (SECURE) in patients with abdominal pain and ultrasound-proven gallstones or sludge compared usual care with a restrictive strategy for selecting patients for cholecystectomy. The restrictive strategy was based on the Rome criteria of biliary colic. The findings showed that the primary outcome of pain reduction was suboptimal with both usual care and the restrictive strategy (non-inferiority of the restrictive strategy not shown). However, the restrictive strategy was associated with a reduction in cholecystectomies by 7·7% compared with usual care.
Implications of all the available evidence
The SECURE trial illustrates that current surgical treatment of patients with gallstones and abdominal symptoms is far from optimal, and is not improved by implementing a more restrictive selection for cholecystectomy. It is important to realise that most international guidelines on management of cholelithiasis include the Rome criteria as part of the diagnostic selection process for cholecystectomy. These findings should encourage physicians involved in the care of patients with gallstones to rethink cholecystectomy, and to be more careful in advising a surgical approach in patients with gallstones and abdominal symptoms.