Division of Surgery, CLINTEC, Karolinska Institutet and Department of Surgical Gastroenterology, Karolinska University Hospital, SE-141 86 Stockholm, Sweden.
JAMA Surg. 2013 May;148(5):471-8. doi: 10.1001/jamasurg.2013.1221.
To describe the process of initiating and organizing a nationwide validated web-based quality registry of gallstone surgery and endoscopic retrograde cholangiopancreatography (ERCP) and to present some clinical data and the impact the registry has had on the clinical treatment of gallstones.
Observational, population-based registry study.
Data from the nationwide Swedish Registry of Gallstone Surgery and ERCP (GallRiks).
From May 1, 2005, to December 31, 2011, 63 685 cholecystectomies (laparoscopic and open) and 37 860 ERCPs have been prospectively registered in GallRiks.
Cholecystectomies, laparoscopic or conventional, as well as ERCP in a population-based setting.
Registrations of all cholecystectomies and ERCPs are performed online by the surgeon or endoscopist. Thirty-day follow-up of both gallstone surgery and ERCP is mandatory, as is an additional 6-month follow-up of the cholecystectomies. Scores on the 36-Item Short Form Health Survey are registered preoperatively and 6 months postoperatively in elective cholecystectomies at selected units.
The 30-day overall complication rate is 6.1% in elective cholecystectomy, 11.2% in urgent cholecystectomy, and 12.0% following ERCP. The use of antibiotic and thromboembolic prophylaxis in elective laparoscopic cholecystectomy in Sweden has decreased by 8.7% and 17.8% (2006-2011), respectively, mainly owing to presentation of GallRiks data both at meetings and published in peer-reviewed publications. The large database has also enabled several research projects, including one demonstrating that the intention to perform intraoperative cholangiography reduced the risk of death after cholecystectomy. The database has reached greater than 90% national coverage and is continuously validated.
GallRiks is a validated national quality registry for gallstone surgery and ERCP, serving as a base for audit of gallstone disease treatment. It also provides a database for clinical research.
描述启动和组织全国性的胆石症手术和内镜逆行胰胆管造影(ERCP)的验证性网络质量登记的过程,并介绍一些临床数据和该登记对胆石症临床治疗的影响。
观察性、基于人群的登记研究。
来自全国性的胆石症手术和 ERCP 瑞典登记处(GallRiks)的数据。
2005 年 5 月 1 日至 2011 年 12 月 31 日期间,GallRiks 前瞻性地登记了 63685 例胆囊切除术(腹腔镜和开放)和 37860 例 ERCP。
基于人群的环境中,腹腔镜或传统的胆囊切除术以及 ERCP。
由外科医生或内镜医生在线进行所有胆囊切除术和 ERCP 的登记。胆石症手术和 ERCP 的 30 天随访是强制性的,胆囊切除术还需要进行额外的 6 个月随访。在选定的单位中,对选择性胆囊切除术进行术前和术后 6 个月的 36 项简短健康调查评分登记。
选择性胆囊切除术的 30 天总体并发症发生率为 6.1%,紧急胆囊切除术为 11.2%,ERCP 为 12.0%。瑞典选择性腹腔镜胆囊切除术的抗生素和血栓栓塞预防使用率分别下降了 8.7%和 17.8%(2006-2011 年),主要归因于 GallRiks 数据在会议上的展示以及在同行评议出版物上的发表。该大型数据库还支持了几个研究项目,其中一个项目表明,术中胆管造影的意图降低了胆囊切除术后的死亡风险。该数据库的覆盖率已超过 90%,并且正在持续验证中。
GallRiks 是一个经过验证的全国性胆石症手术和 ERCP 质量登记处,可作为胆石病治疗审核的基础。它还为临床研究提供了一个数据库。