胆结石病是工业化社会中常见的胃肠道疾病。据估计,成人胆结石的患病率约为10-15%,大约80%的人仍然无症状。目前,胆囊切除术是有症状的胆结石患者的默认选择。
■评估观察/保守治疗与腹腔镜胆囊切除术的临床和成本效益,以预防在二级护理中出现无并发症的胆结石的成人复发症状和并发症。
■并行组,多中心患者随机优势务实试验,随访长达24个月和嵌入式定性研究。试验内成本-效用和10年马尔可夫模型分析。开发无并发症症状的胆结石疾病的核心结果集。
■二级保健选修设置。
■考虑将有症状的无并发症胆结石疾病转诊至二级保健机构的成年人纳入。
■参与者在诊所以1:1的比例随机分配接受腹腔镜胆囊切除术或观察/保守治疗。
■主要结果是使用ShortForm-36身体疼痛域通过18个月的曲线下面积测量的生活质量。次要结果包括奥塔哥胆结石病情特异性问卷,简短的形式-36域(不包括身体疼痛),ShortForm-36身体疼痛域的曲线下面积超过24个月,持续的症状,并发症,需要进一步治疗。没有结果对分配视而不见。
■在2016年8月至2019年11月期间,来自英国20个中心的434名参与者被随机分组(每组217名)。到24个月,观察/保守治疗组64例(29.5%),腹腔镜胆囊切除术组153例(70.5%)接受手术,中位手术时间为9.0个月(四分位距,5.6-15.0)和4.7个月(四分位数范围2.6-7.9),分别。18个月时,在观察/保守治疗组中,ShortForm-36基于常模的平均身体疼痛评分为49.4(标准差11.7),在腹腔镜胆囊切除术组中为50.4(标准差11.6).两组18个月的平均曲线下面积为46.8,无差异:平均差-0.0,95%置信区间(-1.7至1.7);p值0.996;n=203观察/保守,n=205胆囊切除术。没有证据表明生活质量有差异,并发症或需要在长达24个月的随访中进一步治疗。24个月时特定条件的生活质量有利于胆囊切除术:平均差9.0,95%置信区间(4.1至14.0),p<0.001,持续性症状评分模式相似。试验内成本效用分析发现,24个月内的观察/保守管理比胆囊切除术的成本更低(平均差异-1033英镑)。无显着的质量调整寿命年差异-0.019有利于胆囊切除术,导致增加的成本效益比为55,235英镑。马尔可夫模型继续支持观察/保守管理,但由于长期生活质量的不确定性,一些情景逆转了这一发现.核心结果集包括来自患者和医疗保健专业人员的11个至关重要的结果。
■结果表明,在短期内(长达24个月)观察/保守管理可能是对选定患者的国家卫生服务资源的一种具有成本效益的使用,但随机分组的后续手术和超过24个月的生活质量差异可能会逆转这一发现.未来的研究应集中在长期随访数据和确定应常规手术的患者队列。
■本试验注册为ISRCTN55215960。
■该奖项由美国国家卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖参考:14/192/71)资助,并在《卫生技术评估》中全文发布。28号26.有关更多奖项信息,请参阅NIHR资助和奖励网站。
C-GALL研究评估了其益处,就症状而言,生活质量和成本,胆囊切除术与观察(保守管理:由患者和全科医生进行,如果需要,可能包括饮食建议和疼痛管理和手术)。对有症状的胆结石患者随机分配手术或保守治疗。在接下来的两年中,使用邮政问卷评估了持续的身体疼痛的主要症状和其他一些生活质量指标。两年后,分配给手术的人中有70%进行了手术,而观察组的37%进行了手术或正在等待手术。两组之间的身体疼痛或整体生活质量没有差异。然而,与保守治疗组相比,手术组参与者报告的与胆结石疾病相关或手术后的持续问题较少.手术是,然而,比保守管理更昂贵。C-GALL研究表明,对于一些患者来说,保守的管理方法可能是一种足够且成本较低的管理胆结石症状的方法,而不是直接在等待手术的名单上。需要更多的研究来确定哪些患者从手术中受益最大。
UNASSIGNED: Gallstone disease is a common gastrointestinal disorder in industrialised societies. The prevalence of gallstones in the adult population is estimated to be approximately 10-15%, and around 80% remain asymptomatic. At present, cholecystectomy is the default option for people with symptomatic gallstone disease.
UNASSIGNED: To assess the clinical and cost-effectiveness of observation/conservative management compared with laparoscopic cholecystectomy for preventing recurrent symptoms and complications in adults presenting with uncomplicated symptomatic gallstones in secondary care.
UNASSIGNED: Parallel group, multicentre patient randomised superiority pragmatic trial with up to 24 months follow-up and embedded qualitative research. Within-trial cost-utility and 10-year Markov model analyses. Development of a core outcome set for uncomplicated symptomatic gallstone disease.
UNASSIGNED: Secondary care elective settings.
UNASSIGNED: Adults with symptomatic uncomplicated gallstone disease referred to a secondary care setting were considered for inclusion.
UNASSIGNED: Participants were randomised 1: 1 at clinic to receive either laparoscopic cholecystectomy or observation/conservative management.
UNASSIGNED: The primary outcome was quality of life measured by area under the curve over 18 months using the Short Form-36 bodily pain domain. Secondary outcomes included the Otago gallstones\' condition-specific questionnaire, Short Form-36 domains (excluding bodily pain), area under the curve over 24 months for Short Form-36 bodily pain domain, persistent symptoms, complications and need for further treatment. No outcomes were blinded to allocation.
UNASSIGNED: Between August 2016 and November 2019, 434 participants were randomised (217 in each group) from 20 United Kingdom centres. By 24 months, 64 (29.5%) in the observation/conservative management group and 153 (70.5%) in the laparoscopic cholecystectomy group had received surgery, median time to surgery of 9.0 months (interquartile range, 5.6-15.0) and 4.7 months (interquartile range 2.6-7.9), respectively. At 18 months, the mean Short Form-36 norm-based bodily pain score was 49.4 (standard deviation 11.7) in the observation/conservative management group and 50.4 (standard deviation 11.6) in the laparoscopic cholecystectomy group. The mean area under the curve over 18 months was 46.8 for both groups with no difference: mean difference -0.0, 95% confidence interval (-1.7 to 1.7); p-value 0.996; n = 203 observation/conservative, n = 205 cholecystectomy. There was no evidence of differences in quality of life, complications or need for further treatment at up to 24 months follow-up. Condition-specific quality of life at 24 months favoured cholecystectomy: mean difference 9.0, 95% confidence interval (4.1 to 14.0), p < 0.001 with a similar pattern for the persistent symptoms score. Within-trial cost-utility analysis found observation/conservative management over 24 months was less costly than cholecystectomy (mean difference -£1033). A non-significant quality-adjusted life-year difference of -0.019 favouring cholecystectomy resulted in an incremental cost-effectiveness ratio of £55,235. The Markov model continued to favour observation/conservative management, but some scenarios reversed the findings due to uncertainties in longer-term quality of life. The core outcome set included 11 critically important outcomes from both patients and healthcare professionals.
UNASSIGNED: The results suggested that in the short term (up to 24 months) observation/conservative management may be a cost-effective use of National Health Service resources in selected patients, but subsequent surgeries in the randomised groups and differences in quality of life beyond 24 months could reverse this finding. Future research should focus on longer-term follow-up data and identification of the cohort of patients that should be routinely offered surgery.
UNASSIGNED: This trial is registered as ISRCTN55215960.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/192/71) and is published in full in Health Technology Assessment; Vol. 28, No. 26. See the NIHR Funding and Awards website for further award information.
The C-GALL study assessed the benefits, in terms of symptoms, quality of life and costs, of cholecystectomy versus observation (conservative management: by the patient and general practitioner that might include dietary advice and pain management and surgery if needed). Four hundred and thirty-four patients with symptomatic gallstones were randomly allocated surgery or conservative management. The main symptom of ongoing bodily pain and some other quality-of-life measures were assessed over the next 2 years using postal questionnaires. After 2 years, 70% of those allocated to surgery had been operated on and 37% of the observation group either had an operation or were waiting for one. There was no difference in bodily pain or overall quality of life between the groups. However, participants in the surgery group reported fewer ongoing problems related to their gallstone disease or after surgery than those in the conservative management group. Surgery was, however, more costly than conservative management. The C-GALL study has shown that for some patients, a conservative management approach may be a sufficient and less costly way of managing their gallstone symptoms rather than going straight on the waiting list for surgery. More research is needed to identify which patients benefit most from surgery.