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临床试验/NCT03954561
NCT03954561已完成不适用

Abdominal Compression Administered Early by the Colonoscopist Shortened Insertion Time of Water Exchange Colonoscopy

Dalin Tzu Chi General Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
cecal intubation time

研究概览

简要总结

Loop formation is the most frequent cause of cecal intubation failure during colonoscopy. To reduce the loop formation, external abdominal pressure is widely used and proved to be helpful. Properly applied pressure can also decrease patients discomfort and shorten the cecal intubation time.

The loop formation during water exchange is less severe as compared with during air insufflation and can be reduced quite readily. Traditionally an assistant is not asked to administer abdominal compression until the endoscopist has struggled for some time and failed to reduce the loops by withdrawal. The colonoscopist can administer the abdominal compression whenever the scope is not advancing smoothly, probably in the early stage of loop formation. We test the hypothesis that colonoscopist administered abdominal compression to remove loops in their early stage of formation hastens cecal intubation.

A total of 120patients will be randomized in a 1:1 ratio (n=60 per group). When the tip of the scope doesn't advance or paradoxical movements occur, loop reduction by withdrawal of the scope will be implemented. If looping persists, abdominal compression will be applied. In the endoscopist-administered abdominal compression (endoscopist) group, the colonoscopist will apply the compression with his right hand and counter the pressure by pushing the back of the patient with his left forearm with the colonoscope in his left hand. The compression will be administered at left lower quadrant when the scope is in the sigmoid colon and at left lower quadrant and upper abdomen, respectively, when the scope tip reaches the transverse or ascending colon. If the formation of loop cannot be overcome, an assistant will apply the abdominal compression instead. In the assistant-administered abdominal compression (assistant) group, an endoscopic assistant will apply abdominal compression when a loop is formed. The assistant will apply the compression at the left lower quadrant initially, but quickly shift to other parts as needed depending on the tip location of colonoscope. If manual compressions fail, then the patients' position will be changed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •In the Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.
  • •Patients who undergo WE colonoscopy performed by the two endoscopists (YHH and CWT) at the endoscopic suite will be included.

排除标准

  • •Included patient declined to give consent,
  • •age <20 years old,
  • •age >80 years old,
  • •previous partial colectomy, not completely consumed bowel prep regimen, massive ascites, or known colonic obstruction, morbid obesity (BMI ≥ 35).

研究组 & 干预措施

endoscopist group

Experimental

endoscopist-administered abdominal compression group

干预措施: endoscopist-administered abdominal compression (Procedure)

assistant group

Active Comparator

assistant-administered abdominal compression group

干预措施: assistant-administered abdominal compression (Procedure)

结局指标

主要结局

cecal intubation time

时间窗: through study completion, average 15 minutes

the time when the colonoscope is inserted from the anus to the cecum.

次要结局

  • proportion of patients requiring abdominal compression by an assistant(through study completion, average 15 minutes)

研究者

发起方
Dalin Tzu Chi General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu-Hsi hsieh

Chief of Gastroenterology Endoscopy Suite

Dalin Tzu Chi General Hospital

研究点 (1)

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