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The use of Ursolit for gallstone prophylaxis following bariatric surgery: a randomized-controlled trial
Abstract
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/m 2 , 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…
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Patients undergoing bariatric surgery experienced difficulty in tolerating either the size or structure of the tablet, rather than the content.
“indicating that patients undergoing bariatric surgery experienced difficulty in tolerating either the size or structure of the tablet, rather than the content.8,37,38”
The moderate overall compliance of 63% in our trial is consistent with compliance rates reported in other trials.
“The moderate overall compliance of 63% in our trial is consistent with compliance rates reported in other trials, 6,8,35,36 although higher rates have been reported as well.7,25,37,38”
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CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials
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Haal, S., Guman, M. S. S., Boerlage, T. C. C., Acherman, Y. I. Z., de Brauw, L. M., Bruin, S., de Castro, S. M. M., van Hooft, J. E., van de Laar, A. W. J. M., Moes, D. E., et al. (2021) · The Lancet Gastroenterology & Hepatology · doi:10.1016/s2468-1253(21)00301-0 · Cited by 82
Son, S.-Y., Song, J. H., Shin, H.-J., Hur, H., & Han, S.-U. (2022) · Journal of Metabolic and Bariatric Surgery · doi:10.17476/jmbs.2022.11.2.30 · Cited by 23
Metadata
- Authors
- Sakran, N., Dar, R., Assalia, A., Neeman, Z., Farraj, M., Sherf-Dagan, S., Gralnek, I. M., Hazzan, R., Mokary, S. E., Nevo-Aboody, H., Dola, T., Kaplan, U., & Hershko, D.
- ORCID
- Sakran, Nasser
- Venue
- Updates in Surgery
- Published
- 2020-07-14
- Volume
- 72
- Issue
- 4
- Pages
- 1125-1133
- ISSN
- 2038-131X
- 2038-3312
- Cited by
- 29
- References
- 4
- Language
- en
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