Department of Surgery, NHS Grampian, Aberdeen, UK.
Health Services Research Unit, University of Aberdeen Health Services Research Unit, Aberdeen, UK.
BMJ Open. 2021 Mar 25;11(3):e039781. doi: 10.1136/bmjopen-2020-039781.
Gallstone disease (cholelithiasis) is common. In most people it is asymptomatic and does not require treatment, but in about 20% it can become symptomatic, causing pain and other complications requiring medical attention and/or surgery. A proportion of symptomatic people with uncomplicated gallstone disease do not experience further episodes of pain and, therefore, could be treated conservatively. Moreover, surgery carries risks of perioperative and postoperative complications.
C-Gall is a pragmatic, multicentre, randomised controlled trial and economic evaluation to assess whether cholecystectomy is cost-effective compared with observation/ conservative management (here after referred to as medical management) at 18 months post-randomisation (with internal pilot).
Patient-reported quality of life (QoL) (36-Item Short Form Survey (SF-36) bodily pain domain) up to 18 months after randomisation.The primary economic outcome is incremental cost per quality-adjusted life year gained at 18 months.
Secondary outcome measures include condition-specific QoL, SF-36 domains, complications, further treatment, persistent symptoms, healthcare resource use, and costs assessed at 18 and 24 months after randomisation. The bodily pain domain of the SF-36 will also be assessed at 24 months after randomisation.A sample size of 430 participants was calculated. Computer-generated 1:1 randomisation was used.The C-Gall Study is currently in follow-up in 20 UK research centres. The first patient was randomised on 1 August 2016, with follow-up to be completed by 30 November 2021.
Statistical analysis of the primary outcome will be intention-to-treat and a per-protocol analysis. The primary outcome, area under the curve (AUC) for the SF-36 bodily pain up to 18 months, will be generated using the Trapezium rule and analysed using linear regression with adjustment for the minimisation variables (recruitment site, sex and age). For the secondary outcome, SF-36 bodily pain, AUC up to 24 months will be analysed in a similar way. Other secondary outcomes will be analysed using generalised linear models with adjustment for minimisation and baseline variables, as appropriate. Statistical significance will be at the two-sided 5% level with corresponding CIs.
The North of Scotland Research Ethics Committee approved this study (16/NS/0053). The dissemination plans include Health Technology Assessment monograph, international scientific meetings and publications in high-impact, open-access journals.
ISRCTN55215960; pre-results.
胆石病（胆结石）很常见。在大多数人中，它是无症状的，不需要治疗，但在大约 20%的病例中，它可能会出现症状，导致疼痛和其他需要医疗关注和/或手术的并发症。一部分有简单胆石病症状的患者不会再出现疼痛发作，因此可以进行保守治疗。此外，手术有围手术期和术后并发症的风险。
C-Gall 是一项实用的、多中心的、随机对照试验和经济评估，旨在评估与观察/保守治疗（以下简称医学治疗）相比，胆囊切除术在随机分组后 18 个月时的成本效益（内部试点）。
患者报告的生活质量（QoL）（36-项简短表格调查（SF-36）身体疼痛领域），直到随机分组后 18 个月。主要的经济结局是 18 个月时每获得一个质量调整生命年的增量成本。
次要结局包括特定于病情的 QoL、SF-36 领域、并发症、进一步治疗、持续症状、医疗资源使用和成本，在随机分组后 18 个月和 24 个月进行评估。SF-36 的身体疼痛领域也将在随机分组后 24 个月进行评估。计算了 430 名参与者的样本量。使用计算机生成的 1:1 随机化。C-Gall 研究目前正在英国 20 个研究中心进行随访。第一个患者于 2016 年 8 月 1 日随机分组，随访将于 2021 年 11 月 30 日完成。
主要结局的统计分析将采用意向治疗和方案分析。主要结局是 SF-36 身体疼痛的 AUC，直到 18 个月，将使用梯形规则生成，并使用线性回归进行分析，调整最小化变量（招募地点、性别和年龄）。对于次要结局，SF-36 身体疼痛，AUC 直到 24 个月，将以类似的方式进行分析。其他次要结局将根据需要，使用广义线性模型进行分析，调整最小化和基线变量。统计显著性将在双侧 5%水平，并相应的 CIs。
苏格兰北部研究伦理委员会批准了这项研究（16/NS/0053）。传播计划包括卫生技术评估专论、国际科学会议和高影响力、开放获取期刊的出版物。
ISRCTN55215960；预结果。
