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2025年1月6日

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Cleveland Clinic Florida
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.
状态: 已完成
最后更新: 上个月

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2025年1月6日

结束日期

2025年9月24日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Cleveland Clinic Florida

责任方

Principal Investigator

主要研究者

Asad Ur Rahman, Fnu

Medical Director, Inflammatory Bowel Disease Center

Cleveland Clinic Florida

入排标准

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)