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临床试验/NCT06776913
NCT06776913已完成不适用

Randomized Controlled Trial Comparing Adult to Pediatric Colonoscope in Obese Patients.

Cleveland Clinic Florida1 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2025年1月6日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
244
试验地点
1
主要终点
Composite of Reaching the Cecum in Less Than 10 Minutes Without Changing the Scope Type.

研究概览

简要总结

The goal of this study is to test which colonoscope works best in people who are above a certain body mass index. Currently, both pediatric and adult colonoscopes are accepted as standard treatments in colonoscopies. Endoscopist pick which one to use based on personal preference and what is available.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • BMI greater than 30
  • Screening and surveillance colonoscopy

排除标准

  • Colon surgery
  • Therapeutic colonoscopy
  • Inflammatory bowel disease
  • Terminated procedure due to stool burden, stenosis, or obstructive mass.
  • Colonoscopy for anemia
  • History of incomplete colonoscopy due to technical difficulties

结局指标

主要结局

Composite of Reaching the Cecum in Less Than 10 Minutes Without Changing the Scope Type.

时间窗: During Surgery, up to 10 minutes

The outcome aims to measure the difficult colonoscope which is defined as either not reaching the cecum, needing more than 10 minutes, or the need to exchange to a different device.

次要结局

  • Number of Participants With Successful Advancement of Colonoscope to the Cecum(During Surgery)
  • Number of Participants With Successful Advancement of Colonoscope to the Terminal Ileum(During Surgery)
  • Time Taken to Advance the Colonoscope From the Rectum to the Cecum.(During Surgery)
  • Time Taken to Withdraw Colonoscope From Cecum to Rectum (Withdrawal Time)(During Surgery)
  • Ancillary Maneuvers Used to Facilitate Colonoscope Advancement(During Surgery)

研究者

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

Asad Ur Rahman, Fnu

Medical Director, Inflammatory Bowel Disease Center

Cleveland Clinic Florida

研究点 (1)

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