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常规结肠镜检查中磁内镜成像与标准结肠镜检查的随机对照试验。

Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial.

机构信息

Department of Medicine, Sorlandet Hospital Kristiansand, Kristiansand, Norway.

出版信息

Gastrointest Endosc. 2011 Jun;73(6):1215-22. doi: 10.1016/j.gie.2011.01.054. Epub 2011 Apr 8.

Abstract

BACKGROUND

Knowing the position of the endoscope within the abdomen is important for performing a high-quality, painless colonoscopy. The recently introduced magnetic endoscopic imaging (MEI) system provides a continuous, real-time image of the endoscope during the entire procedure.

OBJECTIVE

To compare MEI versus standard colonoscopy with on-demand fluoroscopy on unsedated patients, as performed by experienced and inexperienced endoscopists.

DESIGN

Randomized, controlled trial.

SETTING

Endoscopy outpatient clinic.

PATIENTS

This study involved 810 consecutive patients (391 randomized to standard group; 419 randomized to MEI) referred for colonoscopy.

INTERVENTION

MEI or standard approach (involving on-demand fluoroscopy) during colonoscopy.

MAIN OUTCOME MEASUREMENTS

Perceived patient pain and cecal intubation rate and time to cecum.

RESULTS

For inexperienced endoscopists, the cecal intubation rate was significantly higher in the MEI group (77.8%) compared with the standard group (56.0%), P = .02 but not for experienced endoscopists (94.0% for MEI and 96.0% for standard group, P = .87). Inexperienced endoscopists had less need for assistance from a senior colleague when they used MEI (18.5%) compared with the standard technique (40.0%), P = .02. Mean (± standard deviation) time to reach the cecum was 14.0 ± 12.2 minutes in the MEI group and 15.3 ± 14.2 minutes in the standard group, P = .67.

LIMITATIONS

Single center, unblinded study.

CONCLUSION

Inexperienced endoscopists improved their colonoscopy performance when they used MEI, compared with the standard technique, but experienced endoscopists did not. The MEI may be advantageous to use for colonoscopy centers educating endoscopists. (

CLINICAL TRIAL REGISTRATION NUMBER

NCT00519129.).

摘要

背景

了解内镜在腹部的位置对于进行高质量、无痛的结肠镜检查非常重要。最近推出的磁内镜成像(MEI)系统可在整个过程中为内镜提供连续的实时图像。

目的

比较 MEI 与标准结肠镜检查在非镇静患者中的应用,由经验丰富和经验不足的内镜医生进行操作。

设计

随机对照试验。

设置

内镜门诊。

患者

这项研究涉及 810 例连续患者(391 例随机分为标准组;419 例随机分为 MEI 组),均接受结肠镜检查。

干预

MEI 或标准方法(涉及按需透视)进行结肠镜检查。

主要观察指标

患者感知疼痛、盲肠插管率和到达盲肠的时间。

结果

对于经验不足的内镜医生,MEI 组盲肠插管率(77.8%)明显高于标准组(56.0%),P=0.02,但对于经验丰富的内镜医生,两组间差异无统计学意义(MEI 组 94.0%,标准组 96.0%,P=0.87)。与标准技术相比,经验不足的内镜医生在使用 MEI 时需要资深同事协助的情况更少(18.5%对 40.0%),P=0.02。到达盲肠的平均(±标准差)时间,MEI 组为 14.0±12.2 分钟,标准组为 15.3±14.2 分钟,P=0.67。

局限性

单中心、非盲法研究。

结论

与标准技术相比,经验不足的内镜医生在使用 MEI 时提高了结肠镜检查的性能,但经验丰富的内镜医生并未如此。对于内镜培训中心而言,MEI 可能更具优势。(临床试验注册号:NCT00519129)。

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