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.
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DOI：
10.1136/bmj-2023-075383
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发表时间：
2023-12-06
影响因子：
105.7
通讯作者：
Ramsay, Craig
中科院分区：
文献类型：
--
作者：
Ahmed, Irfan;Hudson, Jemma;Innes, Karen;Hernandez, Rodolfo;Gillies, Katie;Bruce, Rebecca;Bell, Victoria;Avenell, Alison;Blazeby, Jane;Brazzelli, Miriam;Cotton, Seonaidh;Croal, Bernard;Forrest, Mark;MacLennan, Graeme;Murchie, Peter;Wileman, Samantha;Ramsay, Craig
目的：评价在成人无症状性胆石病患者中，保守治疗与腹腔镜胆囊切除术预防症状和并发症的临床和成本效益。平行组，务实随机，优势试验。英国的20个二级护理中心。在2016年8月至2019年11月期间，434名患有无复杂症状性胆石症的成人(>；18岁)转诊至二级护理，评估其资格，并随机分配(1：1)接受保守治疗或腹腔镜胆囊切除术。保守治疗或外科手术切除胆囊术。患者的主要结果是生活质量，以曲线下面积衡量，使用简明36(SF-36)身体疼痛领域，超过18个月，得分越高(范围0-100)，表明生活质量更好。其他结果包括NHS的成本、质量调整寿命年(QALY)和增量成本效益比。在接受资格评估的2667名患者中，434名是随机的：217名进入保守治疗组，217名进入腹腔镜组。到18个月时，保守治疗组的54名(25%)和胆囊切除组的146名(67%)接受了手术。保守治疗组基于SF-36标准的平均躯体疼痛评分为49.4(标准差11.7)，而胆囊切除组为50.4(11.6)。18个月前SF-36曲线下的躯体疼痛面积无差异(平均差值为0.0，95%可信区间−为1.7~1.7；P=1.00)。保守治疗的成本较低(平均差异−GB1033(−$1334；−EURO1205)，95%可信区间−GB1413至−GB632)，QALY无差异(平均差异−0.019，95%可信区间−0.06至0.02)。在短期内(≤18个月)，对于无复杂症状性胆石病的成人，腹腔镜手术并不比保守治疗更有效，因此应该考虑将保守治疗作为手术的替代选择。从英国国民健康保险制度的角度来看，保守治疗对于无并发症的症状性胆结石疾病可能是具有成本效益的。由于两组患者的费用、并发症和收益将持续超过18个月，未来的研究应将重点放在更长期的随访上，以确定有效性和终生成本效益，并确定哪些患者应该常规接受手术。ISRCTN注册表ISRCTN55215960。
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. Parallel group, pragmatic randomised, superiority trial. 20 secondary care centres in the UK. 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. Conservative management or surgical removal of the gallbladder. 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. 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). 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. ISRCTN registry ISRCTN55215960.
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影响因子：
13.5
作者：
BARBARA, L;SAMA, C;NARDIN, F
通讯作者：
NARDIN, F
DOI：
10.7326/0003-4819-119-7_part_1-199310010-00011
发表时间：
1993-10-01
影响因子：
39.2
作者：
RANSOHOFF, DF;GRACIE, WA;TRAYNOR, MV
通讯作者：
TRAYNOR, MV
影响因子：
1.9
作者：
JORGENSEN, T;TEGLBJERG, JS;THORVALDSEN, P
通讯作者：
THORVALDSEN, P
影响因子：
2.9
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
通讯作者：
Ramsay C
影响因子：
7.2
作者：
FRIEDMAN, GD;RAVIOLA, CA;FIREMAN, B
通讯作者：
FIREMAN, B