Optimalisatie van de indicatiestelling voor galblaasoperaties*

Objective

To compare usual care and a restrictive strategy in patients with abdominal pain and gallstones with regard to pain-free status after 12 months and the percentage of cholecystectomies.

Design

Randomized prospective non-inferiority study.

Method

The SECURE trial was a randomized trial in 24 academic and peripheral hospitals in the Netherlands, involving patients with abdominal pain and gallstones. Patients were randomized to either usual care or a restrictive strategy. The primary outcome measure was the percentage of pain-free patients after a follow-up duration of 12 months.

Results

In the period 2014-2017, 1067 patients with abdominal pain and gallstones were randomized. After 12 months of follow-up, 59.8% (321/537) of patients who received usual care were pain-free, compared to 56.2% (298/530) of patients in the restrictive strategy study arm. Non-inferiority was not demonstrated (difference 3.6%; one-sided 95% lower CI -8.6%; p-value for non-inferiority = 0.316). The operation rate was significantly lower amongst restrictive strategy patients when compared to usual care (67.7% versus 75.4%, p = 0.005). Time to pain-free status (regardless of surgery or conservative management) was comparable for both study arms (median of 7 months in both groups).

Conclusion

Current usual care for patients with abdominal pain and gallstones is suboptimal. Forty percent of patients are not pain-free a year after receiving a diagnosis of gallstones. The proposed restrictive strategy is associated with fewer operations, but may lead to even fewer pain-free patients.

Conflict of interest and financial support: potential conflicts of interest have been reported for this article. An ICMJE form provided by the author is available online along with the full text of this article.