跳至主要内容
临床试验/NCT01933867
NCT01933867已完成不适用

Water-aided Colonoscopy in Patients With Inflammatory Bowel Disease - a Single-center, Single-blinded Randomized Trial

Vitkovice Hospital2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2013年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
2
主要终点
Success rate of unsedated colonoscopy

研究概览

简要总结

Water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms of lower discomfort and need for sedation during colonoscopy. Patients with inflammatory bowel diseases (IBD) undergo repeated colonoscopy in course of their disease. According to our preliminary experience, water immersion could be beneficial while scoping these patients. As far as the investigators know, water-aided colonoscopy has never been studied in this indication. Results of our trial might support use of water-aided colonoscopy in common practice and decrease associated discomfort in IBD patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • known diagnosis of inflammatory bowel disease
  • planned diagnostic outpatient colonoscopy
  • signed informed consent
  • willingness to undergo unsedated colonoscopy

排除标准

  • ulcerative proctitis
  • bowel resection longer than ileocecal resection
  • requirement for sedation

结局指标

主要结局

Success rate of unsedated colonoscopy

时间窗: at the end of each colonoscopy

Successful unsedated colonoscopy is defined as reaching the cecum by using given insertion technique without administering sedation.

次要结局

  • Discomfort during colonoscopy(at the end of each colonoscopy)
  • Cecal intubation time(while reaching the cecum)

研究者

发起方
Vitkovice Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Premysl Falt MD

MUDr. Premysl Falt, Ph.D.

Vitkovice Hospital

研究点 (2)

Loading locations...

相似试验

Water-aided Colonoscopy in Inflammatory Bowel... | 临床试验