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腹部压迫装置在结肠镜检查中的应用:一项随机、假对照试验

Use of an Abdominal Compression Device in Colonoscopy: A Randomized, Sham-Controlled Trial.

作者信息

Crockett Seth D, Cirri Holly O, Kelapure Renuka, Galanko Joseph A, Martin Christopher F, Dellon Evan S

机构信息

Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina.

Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina.

出版信息

Clin Gastroenterol Hepatol. 2016 Jun;14(6):850-857.e3. doi: 10.1016/j.cgh.2015.12.039. Epub 2016 Jan 6.

DOI:10.1016/j.cgh.2015.12.039
PMID:26767313
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4875866/
Abstract

BACKGROUND & AIMS: Looping is a common problem during colonoscopy that prolongs procedure time. We aimed to determine the efficacy and safety of ColoWrap, an external abdominal compression device, with respect to insertion time and other procedural outcomes.

METHODS

We performed a prospective study of outpatients undergoing elective colonoscopy (40-80 years old; mean age, 60.5 years) at endoscopy facilities in the University of North Carolina Hospitals from April 2013 through March 2014. Subjects were randomly assigned to groups that received either ColoWrap (n = 175) or a sham device (control, n = 175) during colonoscopy. Colonoscopists and staff were blinded to the application. The primary outcome was cecal intubation time (CIT). Secondary outcomes included use of manual pressure and position change.

RESULTS

The mean CIT was similar for the control and ColoWrap groups (6.69 vs 6.67 minutes; P = .98). There were no statistical differences in the frequency of manual pressure (45% for controls vs 37% for ColoWrap group, P = .13) or position changes (4% for controls vs 2% for ColoWrap group, P = .36). Among patients with body mass index between 30 and 40 kg/m(2) (n = 78), CIT was significantly lower for patients in the ColoWrap group (4.69 minutes) than controls (6.10 minutes) (P = .03). Adverse events were similar between groups.

CONCLUSIONS

In patients undergoing elective colonoscopy, application of an external abdominal compression device did not improve CIT or affect the frequency of ancillary maneuvers. A possible benefit was observed in patients with body mass index between 30 and 40 kg/m(2), but further studies are needed. ClinicalTrials.gov number: NCT02025504.

摘要

背景与目的

在结肠镜检查过程中,肠管成袢是一个常见问题,会延长检查时间。我们旨在确定一种外部腹部压迫装置ColoWrap在插入时间及其他操作结果方面的有效性和安全性。

方法

2013年4月至2014年3月,我们在北卡罗来纳大学医院的内镜检查科室对接受择期结肠镜检查的门诊患者(年龄40 - 80岁;平均年龄60.5岁)进行了一项前瞻性研究。受试者在结肠镜检查期间被随机分配至接受ColoWrap的组(n = 175)或假装置组(对照组,n = 175)。结肠镜检查医师和工作人员对装置的应用情况不知情。主要结局是盲肠插管时间(CIT)。次要结局包括手动按压的使用情况和体位改变。

结果

对照组和ColoWrap组的平均CIT相似(6.69分钟对6.67分钟;P = 0.98)。手动按压频率(对照组45%对ColoWrap组37%,P = 0.13)或体位改变频率(对照组4%对ColoWrap组2%,P = 0.36)无统计学差异。在体重指数为30至40 kg/m²的患者(n = 78)中,ColoWrap组患者的CIT(4.69分钟)显著低于对照组(6.10分钟)(P = 0.03)。两组间不良事件相似。

结论

在接受择期结肠镜检查的患者中,应用外部腹部压迫装置并未改善CIT或影响辅助操作的频率。在体重指数为30至40 kg/m²的患者中观察到了可能的益处,但仍需进一步研究。ClinicalTrials.gov编号:NCT02025504。

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