The use of Ursolit for gallstone prophylaxis following bariatric surgery: a randomized-controlled trial.

BACKGROUND

Although bariatric surgery (BS) predisposes patients to development of gallstone formation, a preventive strategy is still in debate.

AIM: To compare the incidence of gallstone formation between patients treated with ursodeoxycholic acid (UDCA) vs. placebo for a duration of 6 months following BS.

METHODS

This multicenter randomized, double-blind controlled trial entails treatment with UDCA vs. an identical-looking placebo. The primary outcome was gallstone formation, as measured by abdominal ultrasound.

RESULTS

The data of 209 subjects were enrolled in the study, and 92 subjects completed the study and were analyzed (n = 46 for each study group). The high dropout rate was mainly due to difficulties in adding more medications and swallowing the pill. Among the subjects who completed the study, 77.2% were women, and their mean age and pre-surgery BMI were 42.2 ± 10.2 years and 44.4 ± 6.1 kg/m2, respectively. Gallstone formation was recorded in 45.7% (n = 21) vs. 23.9% (n = 11) of subjects among placebo vs. UDCA groups, respectively, p = 0.029. Subgroup-analysis, according to surgery type, found that the results were significant only for SG subjects (p = 0.041), although the same trend was observed for OAGB/RYGB. Excess Weight Loss percent (%EWL) at 6 months post-surgery was 66.0 ± 17.1% vs. 71.8 ± 19.5% for the placebo and UDCA groups, respectively; p = 0.136. A trend towards a reduction in prescribed comorbidity medications was noted within-groups during the follow-up period, as compared to baseline, with no between-group differences (p ≥ 0.246). Moreover, no between-group differences were found for blood test results (p ≥ 0.063 for all).

CONCLUSION

Administration of UDCA significantly decreased gallstone formation at 6 months at following BS. CLINICALTRIALS.

GOV NUMBER: NCT02319629.