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

医学 生活质量(医疗保健) 随机对照试验 置信区间 胆囊切除术 保守管理 腹腔镜胆囊切除术 心理干预 外科 物理疗法 内科学 精神科 护理部
作者
Irfan Ahmed,Jemma Hudson,Karen Innes,Rodolfo Hernández,Katie Gillies,Rebecca Bruce,Victoria Bell,Alison Avenell,Jane Blazeby,Miriam Brazzelli,Seonaidh Cotton,Bernard Croal,Mark Forrest,Graeme MacLennan,Peter Murchie,Samantha Wileman,Craig Ramsay
标识
DOI:10.1136/bmj-2023-075383
摘要

Abstract 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 .
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
qq完成签到,获得积分10
1秒前
王二哈完成签到,获得积分10
2秒前
行者无疆发布了新的文献求助10
3秒前
令散内方完成签到,获得积分10
3秒前
外向的雁玉完成签到,获得积分10
3秒前
慧灰huihui发布了新的文献求助10
4秒前
Ava应助Desire采纳,获得10
5秒前
量子星尘发布了新的文献求助10
8秒前
风信子完成签到,获得积分10
8秒前
小熊完成签到 ,获得积分10
10秒前
14秒前
shu完成签到,获得积分10
14秒前
14秒前
勤奋的毛豆完成签到,获得积分10
17秒前
行者无疆完成签到,获得积分10
17秒前
18秒前
Jackylee完成签到,获得积分10
18秒前
careyzhou发布了新的文献求助10
19秒前
舒心之云完成签到,获得积分10
21秒前
Desire发布了新的文献求助10
21秒前
独自受罪完成签到 ,获得积分10
22秒前
甘蓝型油菜完成签到,获得积分10
23秒前
Distance发布了新的文献求助10
24秒前
大橙子发布了新的文献求助10
25秒前
毛哥看文献完成签到 ,获得积分10
25秒前
Desire完成签到,获得积分10
27秒前
AiQi完成签到 ,获得积分10
28秒前
月月鸟完成签到 ,获得积分10
29秒前
陈永伟完成签到,获得积分10
31秒前
传奇3应助qq采纳,获得10
31秒前
feihua1完成签到 ,获得积分10
32秒前
大轩完成签到 ,获得积分10
33秒前
miemie66完成签到,获得积分10
34秒前
35秒前
Sun1c7完成签到,获得积分10
35秒前
大仁哥完成签到,获得积分10
35秒前
qqy完成签到,获得积分10
36秒前
失眠的香菇完成签到 ,获得积分10
38秒前
机灵的笼包完成签到,获得积分10
38秒前
兔子发布了新的文献求助10
39秒前
高分求助中
【提示信息,请勿应助】关于scihub 10000
Les Mantodea de Guyane: Insecta, Polyneoptera [The Mantids of French Guiana] 3000
徐淮辽南地区新元古代叠层石及生物地层 3000
The Mother of All Tableaux: Order, Equivalence, and Geometry in the Large-scale Structure of Optimality Theory 3000
Handbook of Industrial Diamonds.Vol2 1100
Global Eyelash Assessment scale (GEA) 1000
Picture Books with Same-sex Parented Families: Unintentional Censorship 550
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 4038201
求助须知:如何正确求助?哪些是违规求助? 3575940
关于积分的说明 11373987
捐赠科研通 3305747
什么是DOI,文献DOI怎么找? 1819274
邀请新用户注册赠送积分活动 892662
科研通“疑难数据库(出版商)”最低求助积分说明 815022