Protocol for a randomised controlled trial comparing laparoscopic cholecystectomy with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones (C-Gall trial).
Protocol for a randomised controlled trial comparing laparoscopic cholecystectomy with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones (C-Gall trial).
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DOI：
10.1136/bmjopen-2020-039781
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发表时间：
2021-03-25
期刊：
影响因子：
2.9
通讯作者：
Ramsay C
中科院分区：
文献类型：
--
作者：
Ahmed I;Innes K;Brazzelli M;Gillies K;Newlands R;Avenell A;Hernández R;Blazeby J;Croal B;Hudson J;MacLennan G;McCormack K;McDonald A;Murchie P;Ramsay C
胆石病（胆石症）是常见的。在大多数人中，它是无症状的，不需要治疗，但在大约20%的人中，它可能会出现症状，引起疼痛和其他并发症，需要医疗照顾和/或手术。一部分有症状的无并发症胆石病患者不会再经历疼痛发作，因此可以保守治疗。此外，手术还存在围手术期和术后并发症的风险。C-Gall是一项实用的、多中心、随机对照试验和经济学评价，旨在评估随机化后18个月（内部试点）胆囊切除术与观察/保守治疗（以下简称医学治疗）相比是否具有成本效益。随机化后长达18个月的患者报告的生活质量（QoL）（36项简表调查（SF-36）身体疼痛领域）。主要经济结果是在18个月时获得的每质量调整生命年的增量成本。次要结局指标包括随机化后18个月和24个月评估的疾病特异性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。还将在随机化后24个月评估SF-36的身体疼痛领域。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个研究中心进行后续研究。首例患者于2016年8月1日接受随机化，随访将于2021年11月30日完成。主要结局的统计分析将是意向治疗和符合方案分析。将使用梯形法则生成主要结局（长达18个月的SF-36身体疼痛曲线下面积（AUC）），并使用线性回归进行分析，调整最小化变量（招募部位、性别和年龄）。对于次要结局，将以类似方式分析SF-36身体疼痛，长达24个月的AUC。将使用广义线性模型分析其他次要结局，并酌情调整最小化和基线变量。统计学显著性将在双侧5%水平及相应CI下进行。苏格兰北部研究伦理委员会批准了本研究（16/NS/0053）。传播计划包括卫生技术评估专著、国际科学会议和在影响力大、开放获取的期刊上发表文章。ISRCTN 55215960;预结果。
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.
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影响因子：
13.5
作者：
BARBARA, L;SAMA, C;NARDIN, F
通讯作者：
NARDIN, F
影响因子：
1.9
作者：
JORGENSEN, T;TEGLBJERG, JS;THORVALDSEN, P
通讯作者：
THORVALDSEN, P
影响因子：
7.2
作者：
FRIEDMAN, GD;RAVIOLA, CA;FIREMAN, B
通讯作者：
FIREMAN, B
影响因子：
1.9
作者：
Berhane, T;Vetrhus, M;Sondenaa, K
通讯作者：
Sondenaa, K
影响因子：
3.6
作者：
Brazzelli, Miriam;Cruickshank, Moira;Ramsay, Craig
通讯作者：
Ramsay, Craig