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Cited by 200Bariatric Surgery and OutcomesGallbladder and Bile Duct DisordersBiliary and Gastrointestinal Fistulas

The DOI matches its Crossref record; 46 of the 46 references it cites were found in a registry or an index; 2 of the 28 sources its claims cite were checked for support.

Gallstone Formation Prophylaxis After Gastric Restrictive Procedures for Weight Loss: A Randomized Double-Blind Placebo-Controlled Trial

Open access
Miller, Karl, Hell, Emanuel, Lang, Barbara, Lengauer, Elisabeth·2003·Annals of Surgery
DOI 10.1097/01.sla.0000094305.77843.cfPMC PMC1356148
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Abstract

In Brief Object: To determine if a 6-month regimen of prophylactic ursodeoxycholic acid is effective in the prevention of gallstones. Summary Background Data: Rapid weight loss after surgery for the treatment of morbid obesity is associated with a high incidence of gallstone formation. Methods: Patients with vertical banded gastroplasty (VBG) and adjustable gastric banding (AGB) were enrolled in this study. A single-center, randomized, double-blind, prospective trial evaluated 500 mg of ursodeoxycholic acid versus placebo, beginning within 3 days after surgery and continuing for 6 months or until gallstone development, for patients with morbid obesity. Transabdominal sonography or abdominal CT scan was obtained preoperatively at 3, 6, 12, and 24 months after surgery or until gallstone formation. Results: From March 1997 to April 2000, 262 patients were submitted to surgery. Seventy-seven patients refused to participate in the study; 43 patients with previous gallstone operation or verified gallstones preoperatively were excluded. Of 152 patients, 76 were randomized to placebo and 76 to 500 mg of ursodeoxycholic acid daily. Preoperative age, sex, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation was significantly less (P = 0.0018, Fisher exact test) frequent with ursodeoxycholic acid than with placebo at 12 months, 3% versus 22%, and 8% versus 30% (P = 0.0022) at 24 months, cholecystectomy in 4.7% versus 12%, respectively (P < 0,02, Fisher exact test). Conclusion: A daily dose of 500 mg of ursodeoxycholic acid for 6 months is effective prophylaxis for gallstone formation following gastric restrictive procedures. This long-term follow-up study was designed to determine if a 6-month regimen of prophylactic ursodeoxycholic acid is effective in the prevention of gallstones after restrictive bariatric surgery. Patients with vertical banded gastroplasty and adjustable gastric banding were enrolled in this study. A daily dose of 500 mg of ursodeoxycholic acid for 6 months is effective prophylaxis for gallstone formation after gastric restrictive procedures.

Overview

AI snapshot

Written from the paper’s full text.

TL;DR

A 6-month regimen of ursodeoxycholic acid 500 mg/d reduced gallstone formation after gastric restrictive bariatric surgery compared with placebo. The benefit persisted at 24 months and was accompanied by fewer cholecystectomies for symptomatic cholelithiasis.

Key findings

  • Gallstone formation was significantly less frequent with ursodeoxycholic acid than placebo at 12 months (3% vs 22%; P = 0.0018, Fisher exact test) and at 24 months (8% vs 30%; P = 0.0022).
  • Over 24 months, cholecystectomy for symptomatic cholelithiasis was performed in 3 ursodeoxycholic acid patients versus 12 placebo patients (4.7% vs 12%; P < 0.02), at a mean of 14.9 ± 4.3 months after bariatric surgery.
  • Preoperative age, sex, weight, BMI, and postoperative weight loss did not differ significantly between groups. Compliance averaged 84% for ursodeoxycholic acid and 79% for placebo; mild/moderate side effects such as nausea and constipation were 9.3% vs 6.6%, with no severe side effects or serious adverse drug reaction withdrawals.
  • The authors conclude that 500 mg/d ursodeoxycholic acid in divided doses for 6 months is effective prophylaxis for gallstone formation after gastric restrictive procedures.

Methods

  • Single-center, randomized, double-blind, placebo-controlled trial in patients undergoing vertical banded gastroplasty (VBG) or adjustable gastric banding (AGB) for morbid obesity; eligibility included age >18 years and BMI ≥40 kg/m², or BMI ≥35 kg/m² with comorbidities. Exclusions included prior cholecystectomy, gallstones, pregnancy/inadequate contraception, and certain concomitant medications.
  • 152 patients were randomized: 76 to placebo and 76 to ursodeoxycholic acid 500 mg/d, beginning within 3 days after surgery and continuing for 6 months or until gallstone development. Follow-up included transabdominal sonography or abdominal CT preoperatively and at 3, 6, 12, and 24 months after surgery or until gallstone formation.
  • Primary efficacy analysis was the proportion developing gallstones in the intent-to-treat for efficacy group (124 patients completed follow-up gallbladder sonography). Statistical testing used Fisher exact test, Wilcoxon-Mann-Whitney-U test, and χ² tests; power calculation assumed 76 patients per group to detect a 20% difference with beta 0.2 and two-sided alpha 0.05.

Limitations

  • The authors report a high dropout rate of 28 patients (18%), possibly related to capsule size, and lower compliance in the VBG group (20 patients, 26%) than in the AGB group (8 patients, 10%). They also note uncertainty about how long ursodeoxycholic acid should be taken and about long-term effectiveness during weight loss.
  • The text makes evident that only 124 of 152 randomized patients were eligible for the intent-to-treat efficacy analysis, and the reported screening/randomization numbers are inconsistent across the abstract and results. Surgical procedure type (VBG vs AGB) was not randomized, limiting subgroup comparisons.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1097/01.sla.0000094305.77843.cf

Cites

46 of 46 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Verification

Claims the paper makes

2 of 28 cited sources checked · 0 supported · 0 flagged · accuracy not yet measured

  • Premisecitation
    § DISCUSSION

    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”
    Quote in the paperSubstantial claim1 of 5 sources checked
    • cites [19] Shiffman ML, Kaplan GD, Brinkman-Kaplan V, et al. Prophylaxis against gallstone formation with ursodeoxycholic acid in patients participating in a very-low-calorie diet program. Ann Intern Med. 1995;122:899–905. [DOI] [PubMed] [Google Scholar] source
    • cites [20] Hood KA, Gleeson D, Ruppin DC, Dowling RH. Gall stone recurrence and its prevention: the British/Belgian Gall Stone Study Group’s post-dissolution trial. Gut. 1993;34:1277–1288. [DOI] [PMC free article] [PubMed] [Google Scholar] source

      The post-dissolution trial studied gallstone recurrence, not new gallstone formation during very low-calorie dieting or after bariatric surgery. Its discussion of post-dissolution treatment says ursodeoxycholic acid may reduce or delay recurrence, but the reduction was not statistically significant and the authors say it did not prevent recurrence. The paper therefore offers limited support for a protective effect, not for the claimed effectiveness in the specified weight-loss settings. (LLM, conf=0.85)

      Experimental — accuracy not yet measured
    • cites [21] Sugerman HJ, Brewer WH, Shiffman ML, et al. 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. Am J Surg. 1995;169:91–96. [DOI] [PubMed] [Google Scholar] source
    • cites [22] Wudel LJ Jr, Wright JK, Debelak JP, et al. Prevention of gallstone formation in morbidly obese patients undergoing rapid weight loss: results of a randomized controlled pilot study. J Surg Res. 2002;102:50–56. [DOI] [PubMed] [Google Scholar] source
    • cites [23] Williams C, Gowan R, Perey BJ. A double-blind placebo-controlled trial of ursodeoxycholic acid in the prevention of gallstones during weight loss after vertical banded gastroplasty. Obes Surg. 1993;3:257–259. [DOI] [PubMed] [Google Scholar] source
  • Findingown data
    § RESULTS

    Mild and moderate side effects such as nausea and constipation were equivalent in both groups: 4 patients in the placebo group (6.6%) and 6 patients in the treatment group (9.3%).

    “Mild and moderate side effects such as nausea and constipation were equivalent in both groups: 4 patients in the placebo (6.6%) and 6 patients in the treatment group (9.3%).”
    Quote in the paperNot a substantial claim
  • Findingown data
    § DISCUSSION

    In this study, cholecystectomy was performed in symptomatic gallstone disease an average of 14.9 ± 4.3 months after bariatric surgery.

    “In our study, cholecystectomy was performed in symptomatic gallstone disease an average of 14.9 ± 4.3 months after bariatric surgery.”
    Quote in the paperNot a substantial claim
  • Findingown data
    § RESULTS

    No severe side effects from medication were observed.

    “No severe side effects from medication were observed.”
    Quote in the paperNot a substantial claim
  • Findingown data
    § RESULTS

    No patient was withdrawn from the study because of a serious adverse drug reaction.

    “No patient was withdrawn from the study because of a serious adverse drug reaction.”
    Quote in the paperNot a substantial claim
  • It may state two separate claims as one. 11
  • Probably not a substantial claim. 8

  • It may state two separate claims as one.

    Premisecitation
    § Abstract

    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”
    Quote in the paperSubstantial claim1 of 4 sources checked
    • cites [20] Hood KA, Gleeson D, Ruppin DC, Dowling RH. Gall stone recurrence and its prevention: the British/Belgian Gall Stone Study Group’s post-dissolution trial. Gut. 1993;34:1277–1288. [DOI] [PMC free article] [PubMed] [Google Scholar] source

      The Abstract describes a randomized trial of ursodeoxycholic acid to prevent gallstone recurrence after complete stone dissolution, not after bariatric surgery. Searches for vertical banded gastroplasty and gastric bypass found no passage addressing either procedure, so our copy cannot verify the claim attached to citation 23. (LLM, conf=0.76)

      Experimental — accuracy not yet measured
    • cites [21] Sugerman HJ, Brewer WH, Shiffman ML, et al. 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. Am J Surg. 1995;169:91–96. [DOI] [PubMed] [Google Scholar] source
    • cites [22] Wudel LJ Jr, Wright JK, Debelak JP, et al. Prevention of gallstone formation in morbidly obese patients undergoing rapid weight loss: results of a randomized controlled pilot study. J Surg Res. 2002;102:50–56. [DOI] [PubMed] [Google Scholar] source
    • cites [23] Williams C, Gowan R, Perey BJ. A double-blind placebo-controlled trial of ursodeoxycholic acid in the prevention of gallstones during weight loss after vertical banded gastroplasty. Obes Surg. 1993;3:257–259. [DOI] [PubMed] [Google Scholar] source

  • It may state two separate claims as one.

    Findingown data
    § RESULTS

    In the VBG group, patients showed noticeably more rapid weight loss, but no significant incident development of gallstone formation was noticed.

    “In the VBG group, patients showed a noticeably more rapid weight loss, but no significant incident development of gallstone formation was noticed.”
    Quote in the paperNot a substantial claim

  • It may state two separate claims as one.

    Findingown data
    § RESULTS

    In the 24-month follow-up, cholecystectomy for symptomatic cholelithiasis was performed in 3 patients in the ursodeoxycholic acid group and 12 patients in the placebo group (reported as 12% versus 4.7%, respectively; P < 0.02).

    “In the 24-month follow-up period, 15 cholecystectomies were performed (mean 14.9 ± 4.3 months after bariatric surgery) in patients with symptomatic cholelithiasis: 3 patients in the ursodeoxycholic group and 12 patients in the placebo group, 12% versus 4.7%, respectively (P < 0,02, Fisher exact test).”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.

    Study design and conductnone given
    § MATERIALS AND METHODS

    The study was approved by the ethical committee of the Landesregierung Salzburg, Austria, and informed consent was obtained from each patient before the procedure and before initiation of the study.

    “The study was approved by the ethical committee of the Landesregierung Salzburg, Austria, a government institution. Informed consent was obtained from each patient before the procedure and before initiation of the study.”
    Quote in the paperNot a substantial claim

  • It may state two separate claims as one.

    Premisecitation
    § Abstract

    Concomitant cholecystectomy in bariatric surgery can be a very difficult procedure with a higher incidence of complications.

    “Concomitant cholecystectomy in bariatric surgery can be a very difficult procedure with a higher incidence of complications.17,18”
    • Also stated in: § DISCUSSION · plain
      “Synchronous cholecystectomy in bariatric surgery can be a very difficult procedure with a higher incidence of complications, especially in the field of laparoscopic surgery.17,18”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [17] Ammori BJ, Vezakis A, Davides D, et al. Laparoscopic cholecystectomy in morbidly obese patients. Surg Endosc. 2001;15:1336–1339. [DOI] [PubMed] [Google Scholar] source
    • cites [18] Angrisani L, Lorenzo M, De Palma G, et al. Laparoscopic cholecystectomy in obese patients compared with nonobese patients. Surg Laparosc Endosc. 1995;5:197–201. [PubMed] [Google Scholar]

  • Probably not a substantial claim.

    Study design and conductown data
    § RESULTS

    One hundred twenty-four patients completed follow-up gallbladder sonography and were eligible for inclusion in the intent-to-treat for efficacy group.

    “One hundred twenty-four patients completed follow-up gallbladder sonography and were eligible for inclusion in the intent-to-treat for efficacy group.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Study design and conductnone given
    § MATERIALS AND METHODS

    The investigation site was blinded from Falk Corporation to the drug codes, except in case of emergency.

    “Investigation site was blinded from Falk Corporation, FRG to the drug codes, except in case of emergency.”
    Quote in the paperNot a substantial claim

  • It may state two separate claims as one.

    Study design and conductown data
    § Abstract

    Preoperative age, sex, weight, BMI, and postoperative weight loss were not significantly different between the ursodeoxycholic acid and placebo groups.

    “Preoperative age, sex, weight, BMI, and postoperative weight loss were not significantly different between groups.”
    • Also stated in: § RESULTS · plain
      “There were no significant differences with respect to age, sex, preoperative weight, or BMI between those receiving medication or placebo in any of the patient groups.”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one.

    Premisecitation
    § DISCUSSION

    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”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [19] Shiffman ML, Kaplan GD, Brinkman-Kaplan V, et al. Prophylaxis against gallstone formation with ursodeoxycholic acid in patients participating in a very-low-calorie diet program. Ann Intern Med. 1995;122:899–905. [DOI] [PubMed] [Google Scholar] source
    • cites [21] Sugerman HJ, Brewer WH, Shiffman ML, et al. 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. Am J Surg. 1995;169:91–96. [DOI] [PubMed] [Google Scholar] source

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Premisecitation
    § Abstract

    Between 10% and 25% of persons having lost weight through very low-calorie dieting develop gallstones.

    “Between 10% and 25% of persons having lost weight through very low-calorie dieting (VLCD) develop gallstones.12,13”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [12] Yang H., Peterson GM., Roth MP, et al. Risk factors for gallstone formation during rapid weight loss. Dig Dis Sci. 1992;37:912–918. [DOI] [PubMed] [Google Scholar] source
    • cites [13] Zapata R, Severin C, Manriquez M, et al. Gallbladder motility and lithogenesis in obese patients during diet-induced weight loss. Dig Dis Sci. 2000;45:421–428. [DOI] [PubMed] [Google Scholar] source

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Premisecitation
    § Abstract

    35-38% of patients with morbid obesity develop gallstones as they lose weight after bariatric surgery.

    “In addition, 35–38% of patients with morbid obesity develop gallstones as they lose weight after bariatric surgery.5,14,15”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [5] Amaral JF, Thompson WR. Gallbladder disease in morbidly obese. Am J Surg. 1985;149:551–557. [DOI] [PubMed] [Google Scholar] source
    • cites [14] Deitel M, Petrov I. Incidence of symptomatic gallstones after bariatric operations. Surg Gynecol Obstet. 1987;164:549–552. [PubMed] [Google Scholar]
    • cites [15] Shiffman ML, Sugerman HJ, Kellum JM, et al. Changes in gallbladder bile composition following gallstone formation and weight reduction. Gastroenterology. 1992;103:214–221. [DOI] [PubMed] [Google Scholar] source

  • Probably not a substantial claim.

    Study design and conductnone given
    § MATERIALS AND METHODS

    With 76 patients in each treatment group, a difference in proportions of -0.2 (20%) is required to achieve a beta of 0.2 and a sigma of 0.52 on the basis of a two-sided test with a significance level of 0.05.

    “With 76 patients in each treatment group, a difference in proportions of -0.2 (20%) is required to achieve a beta of 0.2 and a sigma of 0.52 on the basis of a two-sided test with a significance level of 0.05.”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one.

    Interpretationreasoning
    § DISCUSSION

    Summarizing the available data on gallstone prevention during rapid weight loss, ursodeoxycholic acid is effective and has few adverse drug reactions.

    “Summarizing the available data on gallstone prevention at the time of rapid weight loss, it is clear that UDCA is effective and has few adverse drug reactions, but its use has not been very common yet.”
    Quote in the paperSubstantial claim

  • It may state two separate claims as one.

    Study design and conductown data
    § RESULTS

    Compliance with the trial drug regimen averaged 79% (60 of 76) for placebo and 84% (64 of 76) for ursodeoxycholic acid.

    “Compliance with the trial drug regimen was similar across the operated subsets and averaged 79% (60 of 76) for placebo and 84% (64 of 76) for ursodeoxycholic acid.”
    Quote in the paperNot a substantial claim

  • It may state two separate claims as one.

    Study design and conductnone given
    § RESULTS

    Patients in the placebo and treatment groups dropped out for the same reasons at similar rates.

    “Patients in the placebo and treatment groups dropped out for same reasons at similar rates.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it.

    Study design and conductnone given
    § MATERIALS AND METHODS

    No financial support, grant, or donation was submitted by the Falk Corporation.

    “No financial support, grant, or donation was submitted by the Falk Corporation.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.

    Study design and conductown data
    § MATERIALS AND METHODS

    The trial was single-center, randomized, double-blind, and prospective.

    “A single-center, randomized, double-blind, prospective trial evaluated 250 mg of ursodeoxycholic acid twice a day (total dosage of 500 mg/d) versus placebo”
    • Also stated in: § Abstract · plain
      “A single-center, randomized, double-blind, prospective trial evaluated 500 mg of ursodeoxycholic acid versus placebo”
    Quote in the paperNot a substantial claim
17 of 17

  • The paper relies on this without support.

    Gallstone formation is correlated with weight loss.

    “It is generally accepted that gallstone formation is correlated with weight loss.”
1 of 1

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • 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”

    From Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery (UPGRADE): a multicentre, double-blind, randomised, placebo-controlled superiority trial (2021) · cites this paper as [37]

    The Results report that 24 protocol violators could not swallow the medication and that placebo and treatment patients dropped out for similar reasons at similar rates. The Discussion suggests capsule size may have contributed, but treats that explanation as possible rather than established; it does not specifically assess tablet structure. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Reported nonparticipants exceed the available patient total

    Major

    The 130 patients said to have refused or been ineligible, plus the two randomized groups of 76, total 282-not the 262 patients submitted to surgery.

    Reported 262 · recomputed 282

  • Cholecystectomy percentages are reversed in the Results

    Minor

    The Results assign 12% to the ursodeoxycholic group and 4.7% to placebo, despite reporting fewer cholecystectomies in the former group. The abstract assigns those percentages in the opposite order.

2 of 2

Citations

Cites

Flagged first, then by citations

Research works printed but not linked: 1

  1. Hell, 1998, Long term results with vertical banded gastroplasty in the treatment of morbid obesity., Obes Surg, 8, 373

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Metadata

Authors
Miller, K., Hell, E., Lang, B., & Lengauer, E.
ORCID
Miller, Karl
Venue
Annals of Surgery
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2003-11
Volume
238
Issue
5
Pages
697-702
ISSN
0003-4932 (ISSN-L)
DOI
10.1097/01.sla.0000094305.77843.cf
PMC
PMC1356148
OpenAlex
W1983687527
Semantic Scholar
8cacff0f9a128f781bfc31ff01cc72506e45fdaa
Cited by
200
References
45
Citations by year
2026: 9 · 2025: 5 · 2024: 2 · 2023: 15 · 2022: 12 · 2021: 7 · 2020: 19 · 2019: 10 · 2018: 9 · 2017: 7 · 2016: 13 · 2015: 8 · 2014: 12 · 2013: 4 · 2012: 10
FWCI
6.76
Type
journal article
Language
en
Open access
Locations
  • Annals of Surgery (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
  • Health Sciences › Medicine › Gastroenterology › Gallbladder and Bile Duct Disorders
  • Health Sciences › Medicine › Gastroenterology › Biliary and Gastrointestinal Fistulas
Keywords
ursodeoxycholic acid, prophylaxis, bariatric surgery, morbid obesity, vertical banded gastroplasty, gastric banding, rapid weight loss, cholecystectomy, gallstone prevention
MeSH terms
Adolescent, Adult, Cholagogues and Choleretics, Double-Blind Method, Female, Humans, Male, Middle Aged, Obesity, Morbid, Postoperative Complications, Prospective Studies, Ursodeoxycholic Acid, Gastroplasty, Cholecystolithiasis, Gallstones

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