The proportion of patients who were pain-free at
12 months’ follow-up, analyzed by intention to treat and per protocol
5% non-inferiority margin was chosen based on
the estimated clinically relevant difference
Based on estimate that the maximum proportion of
pain-free patients following surgery would be 80%
Safety analyses were done in the intention-to
530 assigned to restrictive strategy | 537 assigned to usual care
72% women in usual care | 75% women in restrictive care
Primary outcome: Pain free at 12-month follow-up
Restrictive strategy: 56% (95% CI, 52.0–60.4)
Usual care: 60% (95% CI, 55.6–63.8)
Non-inferiority was not shown: Difference 3.6% (one-sided 95% lower CI −8.6%)
Following cholecystectomy, patients reporting preoperative biliary colic were significantly more often pain-free at 12-month follow-up (p=0.005)
Pre-op colic: 61%
No pre-op colic: 52%
Secondary outcome: Number of cholecystectomies
Restrictive strategy resulted in significantly fewer cholecystectomies than usual care (p=0.01)
Restrictive strategy: 68% | Usual care: 75%
There were no between-group differences in gallstone or surgical complications
Both usual care and the restrictive strategy groups resulted in suboptimal pain reduction for those patients with gallstones and abdominal pain
37% of patients still had pain following surgery
However, the restrictive strategy was associated with fewer cholecystectomies
The authors conclude that patient expectations should be managed prior to surgery and also state
Symptomatic gallstones might be an epiphenomenon of another condition, for which cholecystectomy is not the solution. Further investigation is needed to determine how to best select patients who truly have gallbladder stones, which patients might benefit from cholecystectomy, and whether gallstones and functional gastrointestinal problems coincide.
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