Core outcome set for symptomatic uncomplicated gallstone disease

Innes, Karen; Hudson, Jemma; Banister, Katie; Croal, Bernard; Ramsay, Craig R; Ahmed, Ibrar; Blazeby, Jane M; Gillies, Katie

doi:10.1093/bjs/znac095

Cited by 13 publications

(3 citation statements)

References 14 publications

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“…The two patient and public involvement (PPI) partners (one grant holder/member of the project management group, and one independent member of the trial steering committee) were actively involved in discussions of the study results with the trial steering committee and the trial investigators, and they contributed to preparing the plain English summary. The PPI group (which was initially established as a focus group for the Core Outcome Set 38 but remained actively involved in the wider C-GALL project) was actively involved in discussions of the study results with the PPI partners and contributed to reviewing the plain English summary. At the conclusion of the study, the PPI partners reflected on their input and made suggestions for future research.…”

Section: Patient and Public Involvementmentioning

confidence: 99%

Effectiveness of conservative management versus laparoscopic cholecystectomy in the prevention of recurrent symptoms and complications in adults with uncomplicated symptomatic gallstone disease (C-GALL trial): pragmatic, multicentre randomised controlled trial

Ahmed,

Hudson,

Innes

et al. 2023

BMJ

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Objective To assess the clinical and cost effectiveness of conservative management compared with laparoscopic cholecystectomy for the prevention of symptoms and complications in adults with uncomplicated symptomatic gallstone disease. Design Parallel group, pragmatic randomised, superiority trial. Setting 20 secondary care centres in the UK. Participants 434 adults (>18 years) with uncomplicated symptomatic gallstone disease referred to secondary care, assessed for eligibility between August 2016 and November 2019, and randomly assigned (1:1) to receive conservative management or laparoscopic cholecystectomy. Interventions Conservative management or surgical removal of the gallbladder. Main outcome measures The primary patient outcome was quality of life, measured by area under the curve, over 18 months using the short form 36 (SF-36) bodily pain domain, with higher scores (range 0-100) indicating better quality of life. Other outcomes included costs to the NHS, quality adjusted life years (QALYs), and incremental cost effectiveness ratio. Results Of 2667 patients assessed for eligibility, 434 were randomised: 217 to the conservative management group and 217 to the laparoscopic cholecystectomy group. By 18 months, 54 (25%) participants in the conservative management arm and 146 (67%) in the cholecystectomy arm had received surgery. The mean SF-36 norm based bodily pain score was 49.4 (standard deviation 11.7) in the conservative management arm and 50.4 (11.6) in the cholecystectomy arm. The SF-36 bodily pain area under the curve up to 18 months did not differ (mean difference 0.0, 95% confidence interval −1.7 to 1.7; P=1.00). Conservative management was less costly (mean difference −£1033, (−$1334; −€1205), 95% credible interval −£1413 to −£632) and QALYs did not differ (mean difference −0.019, 95% credible interval −0.06 to 0.02). Conclusions In the short term (≤18 months), laparoscopic surgery is no more effective than conservative management for adults with uncomplicated symptomatic gallstone disease, and as such conservative management should be considered as an alternative to surgery. From an NHS perspective, conservative management may be cost effective for uncomplicated symptomatic gallstone disease. As costs, complications, and benefits will continue to be incurred in both groups beyond 18 months, future research should focus on longer term follow-up to establish effectiveness and lifetime cost effectiveness and to identify the cohort of patients who should be routinely offered surgery. Trial registration ISRCTN registry ISRCTN55215960 .

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Section: Patient and Public Involvementmentioning

confidence: 99%

Effectiveness of conservative management versus laparoscopic cholecystectomy in the prevention of recurrent symptoms and complications in adults with uncomplicated symptomatic gallstone disease (C-GALL trial): pragmatic, multicentre randomised controlled trial

Ahmed,

Hudson,

Innes

et al. 2023

BMJ

Self Cite

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“…Globally, gallstone prevalence affects approximately 10-20% of adults, imposing considerable economic burdens on individuals and societies (1)(2)(3)(4). Approximately 80% of gallstone patients remain asymptomatic; however, without timely intervention, the clinical course of gallstones can progress from asymptomatic carriers to symptomatic and complex conditions such as acute cholecystitis, cholangitis, pancreatitis, and, in rare instances, intestinal obstruction (5,6). Numerous studies have demonstrated that disorders of cholesterol metabolism, unhealthy lifestyle habits, genetic factors, obesity, and pregnancy significantly contribute to the development of gallstone disease (1,(7)(8)(9).…”

Section: Introductionmentioning

confidence: 99%

Investigating the association between blood cobalt and gallstones: a cross-sectional study utilizing NHANES data

Li,

Han,

You

et al. 2024

Front. Public Health

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BackgroundWith the use of cobalt alloys in medical prosthetics, the risk of cobalt exposure has increased. The objective of this study was to investigate the correlation between blood cobalt levels and the occurrence of gallstones utilizing data from the National Health and Nutrition Examination Survey (NHANES).MethodsData collected between 2017 and 2020 were analyzed, encompassing a total of 5,610 participants. Cobalt concentrations in whole blood specimens were directly measured using inductively coupled plasma mass spectrometry (ICP-MS). The presence of gallstones was ascertained through a standardized questionnaire. To assess the association between blood cobalt levels and the presence of gallstones, logistic regression analysis, restricted cubic spline analysis, and subgroup analysis were utilized.ResultsThe results of logistic regression analysis revealed a heightened risk of developing gallstones in the Quartiles 2 and Quartiles 4 groups based on blood cobalt levels when compared to the Quartiles 1 group (OR = 1.54, 95% CI: 1.15–2.07; OR = 1.35, 95% CI: 1.03–1.77). The restricted cubic spline analysis exhibited a positive linear correlation between blood cobalt levels and the occurrence of gallstones. Subgroup analyses further demonstrated a statistically significant correlation between the Quartiles 4 category of blood cobalt levels and an elevated risk of gallstones, particularly among individuals aged 60 years or older, females, those with a body mass index (BMI) equal to or exceeding 25, serum total cholesterol levels below 200 mg/dL, as well as individuals diagnosed with hypertension or diabetes.ConclusionOur study findings indicate a notable association between elevated blood cobalt levels and an increased risk of gallstones. To establish a causal relationship between blood cobalt levels and the elevated risk of developing gallstones, further prospective cohort studies are warranted.

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“…Gallstones are formed in the gallbladder or bile ducts mainly due to unusually high cholesterol or bilirubin levels in the bile. About 80% of people with gallstones are asymptomatic, and about 20% will experience pain and complications related to gallstones [ 3 ]. In addition, if asymptomatic people do not receive timely intervention, asymptomatic people with gallstones will develop more complex diseases such as acute cholecystitis, cholangitis, and pancreatitis, which seriously affect the quality of life [ 4 , 5 ].…”

Section: Introductionmentioning

confidence: 99%

Association between body roundness index (BRI) and gallstones: results of the 2017–2020 national health and nutrition examination survey (NHANES)

Wei,

Zhang

2024

BMC Gastroenterol

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Background Gallstones are associated with obesity, and the BRI is a new obesity index that more accurately reflects body fat and visceral fat levels. The relationship between BRI and gallstone risk is currently unknown, and we aimed to explore the relationship between BRI and gallstone prevalence. Methods A cross-sectional study was conducted utilizing data from the 2017–2020 NHANES involving a total of 5297 participants. To assess the association between BRI and gallstones, we used logistic regression analysis, subgroup analysis, and interaction terms. In addition, we performed restricted cubic spline (RCS) analysis and threshold effects analysis to characterize nonlinear relationships. We assessed the ability of BRI and Body mass index (BMI) to identify gallstones using receiver operating curve (ROC) analysis and area under the curve (AUC), and compared them using the Delong test. Results Of the 5297 participants aged 20 years and older included in the study, 575 had gallstones. In fully adjusted models, a positive association between BRI and gallstone prevalence was observed (OR = 1.16, 95% CI: 1.12–1.20, P < 0.0001). Individuals in the highest quartile of BRI had a 204% increased risk of gallstones compared with those in the lowest quartile (OR = 3.04, 95% CI: 2.19–4.22, P < 0.0001). The correlation between BRI and gallstones persisted in subgroup analyses. RCS analyses showed a nonlinear relationship between BRI and gallstones. The inflection point was further found to be 3.96, and the correlation between BRI and gallstones was found both before and after the inflection point. ROC analysis showed that BRI (AUC = 0.667) was a stronger predictor of gallstones than BMI (AUC = 0.634). Conclusions Elevated BRI is associated with an increased risk of gallstones in the U.S. population, and BRI is a stronger predictor of gallstones than BMI. Maintaining an appropriate BRI is recommended to reduce the incidence of gallstones.

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Core outcome set for symptomatic uncomplicated gallstone disease

Cited by 13 publications

References 14 publications

Effectiveness of conservative management versus laparoscopic cholecystectomy in the prevention of recurrent symptoms and complications in adults with uncomplicated symptomatic gallstone disease (C-GALL trial): pragmatic, multicentre randomised controlled trial

Effectiveness of conservative management versus laparoscopic cholecystectomy in the prevention of recurrent symptoms and complications in adults with uncomplicated symptomatic gallstone disease (C-GALL trial): pragmatic, multicentre randomised controlled trial

Investigating the association between blood cobalt and gallstones: a cross-sectional study utilizing NHANES data

Association between body roundness index (BRI) and gallstones: results of the 2017–2020 national health and nutrition examination survey (NHANES)

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