van Maasakkers Max H G, Weijs Teus J, Goense Lucas, van Lienden Krijn P, van Duijvendijk Peter, Verdonk Robert C, Boerma Djamila
Department of Surgery, St Antonius Hospital, Nieuwegein, Utrecht, The Netherlands
Department of Surgery, St Antonius Hospital, Nieuwegein, Utrecht, The Netherlands.
BMJ Open. 2025 May 13;15(5):e093821. doi: 10.1136/bmjopen-2024-093821.
Cholecystitis is a highly prevalent disease that imposes a substantial burden on the healthcare system. Despite strong underlying evidence, guideline adherence in the treatment of cholecystitis remains low. Moreover, important gaps in knowledge persist that must be addressed to optimise existing guidelines. The primary aim is to assess the nationwide variation in cholecystitis treatment and identify opportunities to improve guideline adherence. Secondary aims include determining the best cystic duct closure method; the best model to predict concomitant choledocholithiasis; the optimal treatment for cholecystitis lasting 7 days or more at diagnosis and the optimal strategy for gallbladder drainage and post-drainage care.
The Dutch CHESS is a multicentre observational cohort study, including 67 out of 69 Dutch hospitals. From 1 April to 30 September 2024, all patients diagnosed with cholecystitis (Tokyo Guidelines definition) will be prospectively identified. Data on patient characteristics, treatment and outcome (with 6-month follow-up) will be collected to address the primary and secondary aims. For the primary aim, guideline adherence is defined as the percentage of patients who undergo early cholecystectomy for cholecystitis lasting 0-7 days. Current adherence, nationally and for each individual hospital, along with predictors of adherence, will be determined. The adherence of each hospital will be set against the national average and best practices. To further support improvement, the impact of guideline adherence on total hospital stay and morbidity will be determined. Three months after performance feedback to the participating hospitals, the impact on local practice will be assessed through questionnaires. Subgroup analyses and statistical methods for addressing both the primary and secondary aims are predefined in this protocol.
The Medical research Ethics Committees United reviewed the protocol and decided that the Dutch Medical Research Involving Human Subjects Act is not applicable (reference Number: W23.225). Approval was obtained from the institutional review board and board of directors at each participating hospital. Results will be disseminated through peer-reviewed publications and conference presentations.
ClinicalTrials.gov, NCT06349863; Pre-results.
胆囊炎是一种高度流行的疾病，给医疗系统带来了沉重负担。尽管有充分的基础证据，但胆囊炎治疗中的指南遵循率仍然很低。此外，知识方面仍存在重要差距，必须加以解决以优化现有指南。主要目的是评估全国范围内胆囊炎治疗的差异，并确定提高指南遵循率的机会。次要目的包括确定最佳的胆囊管闭合方法；预测合并胆总管结石的最佳模型；诊断时胆囊炎持续7天或更长时间的最佳治疗方法，以及胆囊引流和引流后护理的最佳策略。
荷兰CHESS是一项多中心观察性队列研究，包括荷兰69家医院中的67家。从2024年4月1日至9月30日，将前瞻性地确定所有被诊断为胆囊炎（东京指南定义）的患者。将收集有关患者特征、治疗和结局（6个月随访）的数据，以实现主要和次要目的。对于主要目的，指南遵循率定义为因持续0至7天的胆囊炎而接受早期胆囊切除术的患者百分比。将确定全国和每家医院的当前遵循率以及遵循率的预测因素。每家医院的遵循率将与全国平均水平和最佳实践进行对比。为进一步支持改进，将确定指南遵循率对总住院时间和发病率的影响。在向参与医院提供绩效反馈三个月后，将通过问卷调查评估对当地实践的影响。本方案中预先定义了用于实现主要和次要目的的亚组分析和统计方法。
联合医学研究伦理委员会审查了该方案，并决定荷兰涉及人类受试者的医学研究法案不适用（参考编号：W23.225）。已获得各参与医院的机构审查委员会和董事会的批准。结果将通过同行评审出版物和会议报告进行传播。
ClinicalTrials.gov，NCT06349863；预结果。
