Many patients with gallstones and abdominal pain don’t feel better after a procedure to remove their gallbladder, and a recent study suggests this surgery may not always be necessary.
Treatment guidelines in many countries recommend that doctors perform a minimally invasive operation known as a laparoscopic cholecystectomy to remove the gallbladder when patients have abdominal pain associated with gallstones. But in non-emergency cases, there’s no consensus on how doctors should choose which patients might be better off with nonsurgical treatments and lifestyle changes.
For the current study, researchers tested whether patients with gallbladder conditions being treated at outpatient clinics might have better outcomes and less post-operative pain if surgeons adopted a strict set of criteria for operating instead of the “usual care” practice of operating at surgeons’ discretion.
Researchers randomly assigned 537 patients with gallstones and abdominal pain to receive usual care, and 530 patients to get surgery only if they met five criteria: severe pain attacks; pain lasting at least 15 to 30 minutes; pain radiating to the back; pain in the upper abdomen or the right upper quadrant of the abdomen; and pain that responds to pain relief medication.
Pain relief was no better or worse with the restrictive criteria than it was with usual care. With both approaches, at least 40 percent of patients still had abdominal pain 12 months later.
But fewer people had operations with the restrictive criteria: 68 percent compared with 75 percent in the usual care group. This suggests that surgeons need to rethink whether gallstone surgery is necessary in every case and reconsider their criteria for recommending operations, researchers write in The Lancet.
Patients should “be aware that there is a high chance that your gallbladder operation will not resolve all your abdominal pain,” said study co-author Dr. Philip de Reuver, a gastrointestinal surgeon at Radboud University Hospital Nijmegen in the Netherlands.
“A good way to minimize unnecessary surgery is shared decision making,” de Reuver said by email. “Patients should make a list of their symptoms and doctors need to tell which symptoms are most likely to be resolved after surgery and which are less likely or unlikely to be resolved.”
The main goal of the study was to prove “non-inferiority” of restrictive surgical selection criteria as compared with leaving the choice up to the surgeon. To prove this, researchers estimated that there would need to be at least 5 percentage points separating the proportion of patients who were pain-free one year after surgery.
With restrictive criteria, 56 percent of patients were pain-free after 12 months, as were 60 percent of patients with usual care. This difference was too small for the restrictive criteria to be considered “non-inferior” to usual care.
There was no meaningful difference in gallstone complications related to participating in the trial; 8 percent of patients in the usual care group and 7 percent in the restrictive criteria group experienced complications like acute gallbladder pain or pancreatitis.
Surgical complication rates were also similar between the groups, affecting 21 percent of patients in the usual care group and 22 percent in the restrictive criteria group.
At the end of the day, the study suggests that more work is needed to determine the best criteria for selecting patients for surgery, said the co-author of an accompanying editorial, Dr. Kjetil Soreide of the University of Bergen in Norway.
“Jumping to a cholecystectomy may not always yield good outcomes, although many patients do still benefit from having a cholecystectomy,” Soreide said by email.
“One needs to be aware that this is not necessarily a ‘quick fix’ to avoid disappointment after surgery,” Soreide added. “Hopefully further studies will give better insight to what might cause symptoms and when a gallbladder surgery is likely to relieve symptoms.”
By Lisa Rapaport