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A multicenter, placebo-controlled, randomized, double-blind, prospective trial of prophylactic ursodiol for the prevention of gallstone formation following gastric-bypass-induced rapid weight loss
Abstract
Background Previous studies have documented a high incidence of gallstone formation following gastric-bypass (GBP)-induced rapid weight loss in morbidly obese patients. This study was designed to determine if a 6-month regimen of prophylactic ursodiol might prevent the development of gallstones. Methods A multicenter, randomized, double-blind, prospective trial evaluated 3 oral doses of ursodiol: 300, 600, and 1,200 mg versus placebo beginning within 10 days after surgery and continuing for 6 months or until gallstone development, for patients with a body mass index (BMI) > or = 40 kg/m2. All patients had normal intraoperative gallbladder sonography. Transabdominal sonography was obtained at 2, 4, and 6 months following surgery, or until gallstone formation. Results Of 233 patients with at least one postoperative sonogram, 56 were randomized to placebo, 53 to 300 mg ursodiol, 61 to 600 mg ursodiol, and 63 to 1,200 mg ursodiol. Preoperative age, sex, race, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation occurred at 6 months in 32%, 13%, 2%, and 6% of the patients on the respective doses. Gallstones were significantly (P Conclusion A daily dose of 600 mg ursodiol is effective prophylaxis for gallstone formation following GBP-induced rapid weight loss.
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In extremely rapid weight loss and excessive weight reduction, the risk of gallstones occurring increases.
“In both of these cases, the risk of gallstones occurring increases [28,29].”
From Excess Body Weight and Gallstone Disease (2021) · cites this paper as [28]
The increased risks of gallstones with bariatric surgery and very low-calorie diets are approximately 30% and 25%, respectively.
“The increased risks of gallstones have been illustrated with 2 popular weight reduction methods, i.e., bariatric surgery and very low-calorie diets [26][27][28]51], with approximate risks of 30 and 25%, respectively [26,28].”
From Excess Body Weight and Gallstone Disease (2021) · cites this paper as [28]
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”
Only 11 randomized controlled trials have reported the effect of UDCA on gallstone formation after bariatric surgery.
“However, only 11 randomized controlled trials have reported the effect of UDCA on gallstone formation after bariatric surgery (Table 3) [1225264849505152535455].”
From Prevention of Gallstones After Bariatric Surgery using Ursodeoxycholic Acid: A Narrative Review of Literatures (2022) · cites this paper as [25]
The type of bariatric procedure is associated with the incidence and timing of gallstone formation.
“Several studies have implied that the type of bariatric procedure is associated with the incidence and timing of gallstone formation.”
From Prevention of Gallstones After Bariatric Surgery using Ursodeoxycholic Acid: A Narrative Review of Literatures (2022) · cites this paper as [25]
The prophylactic use of UDCA during the weight reduction phase, regardless of the method of weight loss, has been proven to reduce gallstone formation, with reduction rates up to 58% in a few clinical trials.
“The prophylactic use of UDCA during the weight reduction phase, regardless of the method of weight loss (low-calorie diet, bariatric surgery, etc.), has been proven to reduce gallstone formation, with reduction rates of up to 58% in a few clinical trials [2025444546474849].”
From Prevention of Gallstones After Bariatric Surgery using Ursodeoxycholic Acid: A Narrative Review of Literatures (2022) · cites this paper as [25]
The time of gallstone formation differs according to the type of procedure; approximately 30% of gallstones occur within 6 months after RYGB or biliopancreatic diversion, whereas a comparable incidence occurs at 6-12 months after SG.
“previous studies have demonstrated that the time of gallstone formation differs according to the type of procedure; approximately 30% of gallstones were reported within 6 months after Roux-en-Y gastric bypass (RYGB) or biliopancreatic diversion, whereas a comparable incidence was reported at 6–12 months after sleeve gastrectomy (SG) [242526].”
From Prevention of Gallstones After Bariatric Surgery using Ursodeoxycholic Acid: A Narrative Review of Literatures (2022) · cites this paper as [25]
Ursodeoxycholic acid administered during very low-calorie dieting and weight loss after bariatric surgery is effective in preventing gallstone formation.
“Ursodeoxycholic acid administered during VLCD and weight loss after bariatric surgery is effective in preventing gallstone formation19–23”
From Gallstone Formation Prophylaxis After Gastric Restrictive Procedures for Weight Loss: A Randomized Double-Blind Placebo-Controlled Trial (2003) · cites this paper as [21]
The optimum dose for gallstone prophylaxis appears to be 600 mg/d, or 4 to 5 mg/kg.
“The optimum dose for gallstone prophylaxis appears to be 600 mg/d, or 4 to 5 mg/kg.19,21”
From Gallstone Formation Prophylaxis After Gastric Restrictive Procedures for Weight Loss: A Randomized Double-Blind Placebo-Controlled Trial (2003) · cites this paper as [21]
In prospective randomized studies, prophylactic administration of ursodeoxycholic acid has been shown to be effective in gastric bypass procedures, as well as in a small series with vertical banded gastroplasty.
“In prospective randomized studies, the prophylactic administration of ursodeoxycholic acid has been shown to be effective in gastric bypass procedures20–22, as well as in a small series with vertical banded gastroplasty.23”
From Gallstone Formation Prophylaxis After Gastric Restrictive Procedures for Weight Loss: A Randomized Double-Blind Placebo-Controlled Trial (2003) · cites this paper as [21]
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Metadata
- Authors
- Sugerman, H. J., Brewer, W. H., Shiffman, M. L., Brolin, R. E., Fobi, M. A. L., Linner, J. H., MacDonald, K. G., MacGregor, A. M., Martin, L. F., Oram-Smith, J. C., Popoola, D., Schirmer, B. D., & Vickers, F. F.
- Venue
- The American Journal of Surgery
- Publisher
- Elsevier BV
- Published
- 1995-01
- Volume
- 169
- Issue
- 1
- Pages
- 91-97
- ISSN
- 0002-9610
- Cited by
- 336
- References
- 0
- Language
- en
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