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随机对照结直肠癌筛查试验中结肠镜检查后的不良事件。

Adverse events after colonoscopy in a randomised colorectal cancer screening trial.

机构信息

Cancer Registry of Norway, Section for Colorectal Cancer Screening, Norwegian Institute of Public Health, Oslo, Norway.

Clinical Effectiveness Research Group, Institute of Health and Society, University of Oslo, Oslo, Norway.

出版信息

BMJ Open Gastroenterol. 2024 Oct 7;11(1):e001471. doi: 10.1136/bmjgast-2024-001471.

Abstract

OBJECTIVE

Colonoscopy-related adverse events increase the burden of colorectal cancer (CRC) screening. This cross-sectional study evaluates adverse events during and after colonoscopy in a large, randomised CRC screening trial in Norway comparing sigmoidoscopy to immunochemical testing for faecal blood.

METHODS

We included all individuals who underwent colonoscopy at two screening centres between 2012 and 2020. From medical records, we retrieved data on adverse events during and within 30 days after colonoscopy and classified them according to the American Society for Gastrointestinal Endoscopy lexicon for endoscopic adverse events. Multivariable logistic regression models were fitted to identify risk factors for adverse events.

RESULTS

Of the 10 244 included individuals, 242 (2.4%) had at least one adverse event that was possibly, probably, or definitively related to the colonoscopy. 188 (1.8%) had mild adverse events, 50 (0.49%) had moderate, 3 (0.03%) had severe, and 1 had a fatal adverse event. The most frequent adverse events were lower gastrointestinal bleeding (0.86%), abdominal pain (0.48%), vasovagal reaction (0.39%), postpolypectomy syndrome (0.20%), and perforation (0.08%). 23 (0.22%) individuals had non-gastrointestinal adverse events. Risk factors associated with adverse events were older age, female sex, screening centre, anticoagulant therapy, number of polypectomies, size of lesion removed, presence of proximal lesion, and adenocarcinoma. Adverse event rates per endoscopist ranged from 0% to 4.9%.

CONCLUSION

Adverse events after colonoscopy of screening positives occurred in about 2 out of 100 procedures. Three-quarters of events were mild. Awareness of risk factors may help endoscopists to mitigate the risk.

TRIAL REGISTRATION NUMBER

NCT01538550.

摘要

目的

结肠镜检查相关的不良事件增加了结直肠癌(CRC)筛查的负担。本横断面研究评估了在挪威一项比较乙状结肠镜检查与免疫化学粪便潜血检测的大型随机 CRC 筛查试验中,结肠镜检查过程中和检查后发生的不良事件。

方法

我们纳入了 2012 年至 2020 年间在两个筛查中心接受结肠镜检查的所有个体。从病历中,我们检索了结肠镜检查期间和检查后 30 天内不良事件的数据,并根据美国胃肠内镜学会内镜不良事件词汇表对其进行分类。使用多变量逻辑回归模型来确定不良事件的危险因素。

结果

在纳入的 10244 名个体中,有 242 名(2.4%)至少发生了 1 次与结肠镜检查可能、很可能或明确相关的不良事件。188 名(1.8%)发生轻度不良事件,50 名(0.49%)发生中度不良事件,3 名(0.03%)发生严重不良事件,1 名发生致命不良事件。最常见的不良事件是下消化道出血(0.86%)、腹痛(0.48%)、血管迷走神经反应(0.39%)、息肉切除后综合征(0.20%)和穿孔(0.08%)。23 名(0.22%)个体发生非胃肠道不良事件。与不良事件相关的危险因素包括年龄较大、女性、筛查中心、抗凝治疗、息肉切除术数量、切除的病变大小、近端病变存在和腺癌。每位内镜医生的不良事件发生率在 0%至 4.9%之间不等。

结论

筛查阳性者结肠镜检查后的不良事件发生率约为每 100 例 2 例。75%的事件为轻度。了解危险因素可能有助于内镜医生降低风险。

试验注册号

NCT01538550。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9395/11459295/a4296affcad5/bmjgast-11-1-g001.jpg

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