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The use of Ursolit for gallstone prophylaxis following bariatric surgery: a randomized-controlled trial.
- Source :
-
Updates in surgery [Updates Surg] 2020 Dec; Vol. 72 (4), pp. 1125-1133. Date of Electronic Publication: 2020 Jul 14. - Publication Year :
- 2020
-
Abstract
- Background: Although bariatric surgery (BS) predisposes patients to development of gallstone formation, a preventive strategy is still in debate.<br />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.<br />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.<br />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/m <superscript>2</superscript> , 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).<br />Conclusion: Administration of UDCA significantly decreased gallstone formation at 6 months at following BS. CLINICALTRIALS.<br />Gov Number: NCT02319629.
- Subjects :
- Adult
Double-Blind Method
Female
Follow-Up Studies
Gallstones etiology
Humans
Male
Middle Aged
Obesity surgery
Placebo Effect
Postoperative Complications etiology
Time Factors
Bariatric Surgery adverse effects
Gallstones prevention & control
Postoperative Complications prevention & control
Ursodeoxycholic Acid administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 2038-3312
- Volume :
- 72
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Updates in surgery
- Publication Type :
- Academic Journal
- Accession number :
- 32666477
- Full Text :
- https://doi.org/10.1007/s13304-020-00850-2