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临床试验/NCT02208401
NCT02208401已完成不适用

A Prospective Randomised Comparison of Cold Snare Polypectomy Versus Cold Snare Pseudosuction Technique

Sheffield Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2014年1月1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
入组人数
112
试验地点
1
主要终点
Complete macroscopic polyp eradication rate

研究概览

简要总结

Different modalities are employed to remove small colonic polyps which potentially harbour a cancer risk. But, they can all vary in their completeness of removal, safety and the histological quality and the gold standard technique has yet to be defined. A novel suction pseudopolyp technique has been described by Patullo et al and in their prospective study, 126 polyps measuring less than 10mm flat or sessile were removed by this method with 100% complete endoscopic resection and without any immediate or delayed complications. The aim of the investigators study is to compare this technique with the standard cold snare technique. Patients attending for a routine colonoscopy and found to have polyps measuring 37mm in size will be eligible and they will be randomised to the polypectomy technique. Patient demographics and polyp characteristics will be recorded. The primary outcome measured will be the macroscopic resection rate. The secondary outcome measures are abdominal pain, tenderness, bleeding and fever.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Care Provider)

入排标准

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

入选标准

  • •All patients with small polyps 3-7 mm in size, flat or sessile found during colonoscopy

排除标准

  • •Patients are less than 18 years old
  • •Inadequate bowel preparation
  • •On anticoagulants or clopidogrel

研究组 & 干预措施

conventional cold snare polypectomy

Active Comparator

conventional cold snare polypectomy

干预措施: conventional cold snare polypectomy (Procedure)

Cold snare polypectomy with suction

Experimental

Cold snare polypectomy with suction

干预措施: Cold snare polypectomy with suction (Procedure)

结局指标

主要结局

Complete macroscopic polyp eradication rate

时间窗: At time of polypectomy intervention

The primary outcome for this study is the polypectomy completion rate. This will be assessed both macroscopically and histologically. The analysis for statistical difference between the 2 techniques and abdominal symptoms will be compared by the Chi2 test for categorical data.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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