跳至主要内容
临床试验/NCT03016962
NCT03016962Unknown不适用

Usefulness of Cap-assisted Colonoscopy in Patients With Prior Abdominal Surgery: A Randomized, Controlled Trial

The Catholic University of Korea0 个研究点目标入组 1,046 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
1,046
主要终点
Insertion time

研究概览

简要总结

The potential benefit of using the cap is that it helps in luminal orientation at bends by keeping the colonic mucosa away from the lens at the colonoscope tip. Colonoscopy in patients with a history of abdominal surgery is considered to be difficult due to adhesion-related bowel angulations. There were few study evaluating usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery. The investigators designed a randomized, controlled trial to verify the usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery.

详细描述

The potential benefit of using the cap is that it helps in luminal orientation at bends by keeping the colonic mucosa away from the lens at the colonoscope tip. This assists in negotiating sharp turns by better anticipation of the direction. Cap-assisted colonoscopy can be tried as a salvage procedure in cases of failed cecal intubation with regular colonoscopy. Colonoscopy in patients with a history of abdominal surgery is considered to be difficult due to adhesion-related bowel angulations. There were few study evaluating usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery. The investigators designed a randomized, controlled trial to verify the usefulness of cap-assisted colonoscopy in patients with prior abdominal surgery.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with history of abdominal or pelvic surgery

排除标准

  • Previous colorectal resection

研究组 & 干预措施

Cap-assisted colonoscopy

Experimental

cap-assisted colonoscopy

干预措施: cap-assisted colonoscopy (Device)

Standard colonoscopy

Active Comparator

Standard colonoscopy

干预措施: Standard colonoscopy (Device)

结局指标

主要结局

Insertion time

时间窗: Day 1

次要结局

  • Patient discomfort(Day 1)
  • Overall technical ease(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeong-Seon Ji

Dr

The Catholic University of Korea

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