Laparoscopic cholecystectomy for the treatment of symptomatic cholecystolithiasis is currently the standard of care. However, multiple studies indicate that 10-41% of patients continue to have symptoms despite cholecystectomy. This finding warrants investigation of alternative strategies in the treatment of symptomatic gallstone disease. In this randomized controlled non-inferiority trial, 1,067 patients with abdominal pain and ultrasound-proven gallstones or sludge were assigned to either a restrictive strategy involving a stepwise selection for cholecystectomy or to usual care to assess the proportion of patients who were pain-free at 12 months follow-up. In the restrictive strategy group, cholecystectomy was advised for patients who fulfilled all five pre-specified criteria: 1) severe pain attacks, 2) pain lasting 15 to 30 minutes or longer, 3) pain located in the epigastrium or right upper quadrant, 4) pain radiating to the back, and 5) a positive pain response to simple analgesics. In the usual care group, the decision to proceed with cholecystectomy was left to the discretion of the surgeon. At baseline, patients in the restrictive strategy group reported more severe pain attacks than patients in the usual care group (83% vs. 77% respectively, p=0.008), and more patients fulfilled all five pre-specified restrictive strategy criteria in the restrictive strategy group than in the usual care group (38% vs. 28% respectively, p=0.001). Researchers found that the restrictive strategy was not non-inferior to the usual care group in the proportion of pain-free patients at 12 months (56% in the restrictive strategy group vs. 60% in the usual care group, one-sided 95% lower CI -8.6%; p=0.316). There were significantly fewer cholecystectomies performed in the restrictive strategy group (68%) compared to the usual care group (75%) (p=0.01). There were no between-group differences in trial-related complications. This study was limited by the higher proportion of patients reporting severe pain at baseline in the restrictive strategy group, and the fact that some patients in the restrictive strategy group underwent cholecystectomy despite failing to satisfy the cholecystectomy selection criteria. In summary, this study illustrates that current treatment of symptomatic gallstone disease is not improved by a restrictive strategy.
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