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Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery (UPGRADE): A multicentre, double-blind, randomised, placebo-controlled superiority trial

The Lancet: Gastroenterology & Hepatology Oct 31, 2021

Haal S, Guman MSS, Boerlage TCC, et al. - Ursodeoxycholic acid prophylaxis failed to confer a significant reduction in the occurrence of symptomatic gallstone disease in all patients after bariatric surgery.

  • A multicenter, double-blind, randomized, placebo-controlled superiority trial of patients with an intact gallbladder scheduled for laparoscopic Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy.

  • They were randomized to receive either ursodeoxycholic acid or placebo.

  • Post-bariatric surgery, symptomatic gallstone disease occurred in 6·5% and in 9·7% patients in the ursodeoxycholic acid and placebo groups, respectively (relative risk 0·67).

  • Ursodeoxycholic acid showed an effect in patients without asymptomatic gallstones at baseline.

  • Decrease in the occurrence of symptomatic gallstone disease was achieved with ursodeoxycholic acid treatment, vs placebo, in patients without gallstones prior to RYGB surgery.

  • Diarrhea occurred in 0·9% vs 0·4% and skin rash in 0·5% vs 0·4% patients in the ursodeoxycholic acid group vs placebo group, respectively.

  • Ursodeoxycholic acid did not result in any serious adverse event.

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