Patients with gallstones and abdominal pain selected to undergo cholecystectomy implementing either usual care methods or a more restrictive selection strategy experienced suboptimal pain relief, although the restrictive strategy resulted in less cholecystectomies, according to a study published in The Lancet.
A group of investigators for the Scrutinizing the (In)Efficient Use of Cholecystectomy study (SECURE; Netherlands Trial Register, number NTR4022), a randomized, non-inferiority study, compared the use of a restrictive strategy with stepwise selection with usual care — in which selection for cholecystectomy was left to the discretion of the surgeon — to determine the efficiency of cholecystectomy in the reduction of abdominal pain.
Patients aged 18 to 95 years with abdominal pain and gallstones or sludge were randomly assigned either to the usual care group (n=537) or to the restrictive strategy group (n=530). For the restrictive strategy cohort, cholecystectomy was recommended to patients who fulfilled all 5 of the following prespecified criteria: severe pain attacks, pain lasting ≥15 min, pain in the right upper quadrant or epigastrium, pain radiating to the back, and a positive pain response to simple analgesics. The primary outcome was the proportion of pain-free patients at the 12-month follow-up.
At follow-up, 56% of patients (298 of 530) in the restrictive strategy arm and 60% (321 of 537) in the usual care arm were pain free. In addition, cholecystectomies were advised for significantly fewer patients in the restrictive strategy group than in the usual care group (68% vs 75%, respectively).
Trial-related gallstone complications, surgical complications, or non-trials related serious adverse events did not significantly vary between arms.
“[S]urgical treatment for patients with abdominal symptoms and gallstones is indeed far from optimal, and a more restrictive selection for cholecystectomy is not the solution to the problem,” the authors noted.
“These findings should urge surgeons to rethink the pathophysiology of abdominal symptoms in patient candidates for cholecystectomy, and to manage expectations of the surgical approach,” added the investigators.
van Dijk AH, Wennmacker SZ, de Reuver PR, et al for the SECURE trial. Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-interiority trial [published online April 26, 2019]. Lancet. doi:10.1016/S0140-6736(19)30941-9