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医学和护士内镜医师结肠镜检查性能比较:亚洲的一项非劣效性随机对照研究。

Comparison of colonoscopic performance between medical and nurse endoscopists: a non-inferiority randomised controlled study in Asia.

机构信息

Department of Medicine, Alice Ho Miu Ling Nethersole Hospital, Hong Kong, Hong Kong.

Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, Hong Kong.

出版信息

Gut. 2015 Jul;64(7):1058-62. doi: 10.1136/gutjnl-2013-306293. Epub 2014 Dec 18.

Abstract

OBJECTIVE

To test the hypothesis that trained nurse endoscopists are not inferior to medical endoscopists in finding adenomas during colonoscopy.

DESIGN

This is a prospective, randomised, single-blind, non-inferiority study comparing nurses with medical endoscopists in performing screening colonoscopy. The nurse endoscopists had been trained according to the British Joint Advisory Group on GI Endoscopy curriculum and had completed at least 140 colonoscopic procedures prior to the study. The primary endpoint was the adenoma detection rate. Secondary endpoints included the caecal intubation rate, intubation time, complication rate, patient pain and satisfaction scores.

RESULTS

We enrolled and analysed a total of 731 patients over a 15-month period. At least one adenoma was found in 159 (43.8%) of 363 patients by nurse endoscopists and 120 (32.7%) of 367 patients by medical endoscopists and a proportion difference of +11.1% compared with the medical endoscopists (95% CI 4.1% to 18.1%). The withdrawal time was, however, significantly longer among nurses (998 vs 575 s, p<0.001). After adjusting for differences in a regression analysis, colonoscopy by nurses was associated with a lower adenoma detection rate (OR 0.475: 95% CI 0.311 to 0.725). Nurse endoscopists had a lower caecal intubation rate (97.3% vs 100%), received better pain and satisfaction scores and had a high rate of patient acceptance.

CONCLUSIONS

In this pragmatic trial, nurses can perform screening colonoscopy but require a longer procedural time to achieve a comparable adenoma detection rate as medical endoscopists.

TRIAL REGISTRATION NUMBER

NCT01923155.

摘要

目的

验证受训护士内镜医师在结肠镜检查中发现腺瘤方面不逊于医学内镜医师的假设。

设计

这是一项前瞻性、随机、单盲、非劣效性研究,比较护士与医学内镜医师在进行筛查性结肠镜检查方面的表现。护士内镜医师按照英国联合胃肠内镜专家组(British Joint Advisory Group on GI Endoscopy)的课程接受培训,并在研究开始前完成了至少 140 例结肠镜检查。主要终点是腺瘤检出率。次要终点包括盲肠插管率、插管时间、并发症发生率、患者疼痛和满意度评分。

结果

在 15 个月的时间里,我们共纳入并分析了 731 例患者。在 363 例患者中,护士内镜医师发现至少 1 个腺瘤的患者有 159 例(43.8%),而医学内镜医师发现 120 例(32.7%),护士内镜医师与医学内镜医师相比,腺瘤检出率的差异为+11.1%(95%可信区间为 4.1%至 18.1%)。然而,护士的退镜时间明显更长(998 秒 vs 575 秒,p<0.001)。在回归分析中调整差异后,护士进行结肠镜检查与较低的腺瘤检出率相关(OR 0.475:95%可信区间 0.311 至 0.725)。护士内镜医师的盲肠插管率较低(97.3% vs 100%),疼痛和满意度评分较好,且患者接受度较高。

结论

在这项实用试验中,护士可以进行筛查性结肠镜检查,但需要更长的操作时间才能达到与医学内镜医师相当的腺瘤检出率。

试验注册号

NCT01923155。

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