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临床试验/NCT03117114
NCT03117114已完成不适用

Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年6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
发起方
入组人数
250
试验地点
2
主要终点
Polyp resection

研究概览

简要总结

Adenomas are premalignant polyps of the colon that should be resected endoscopically. Complete resection of adenomatous polyps is the major task of colonoscopy. In some cases polyp may be poorly accessible making endoscopic resection difficult. Polypectomy may be conducted using the so-called piece meal technique in these cases. However, leaving polyp residual polyps in the colon bears the risk of malignant degeneration as colorectal cancer may arise form adenomatous remnants. In case of difficult polyp locations endoscopic resection may also be time consuming. On the other hand endoscopists are facing an increased time pressure due to rising numbers of procedures during the last decades.

The Endocuff Vision device (EVD) is a cap that can be mounted to the tip of a standard endoscope. The EVD has small flexible branches on its outside. The branches turn out during withdrawal. By that the branches are getting in contact with colonic wall. This mechanism leads to a more stabilized position of the colonoscope in the bowel. It is hypothesized that resection circumstances may be improved by using an EVD. In addition, stabilizing the scope during resection may result in a reduced time effort. Until now no controlled trials exist investigating the effect of EVD on the time effect during polyp resection. Therefore a randomized controlled trial needed comparing standard polypectomy versus polypectomy using the EVD during routine colonoscopy procedures.

研究设计

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

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • indication for colonoscopy
  • age ≥ 40 years

排除标准

  • American Society of Anesthesiologists class IV or higher
  • pregnant women
  • indication for colonoscopy: inflammatory bowel disease
  • indication for colonoscopy: polyposis syndrome
  • indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
  • contraindication for polyp resection e.g. patients on warfarin
  • Exclusion Criteria:

研究组 & 干预措施

Standard Arm

Other

Standard colonoscopy without mounted Endocuff Vision device. Therefore standard polypectomy in case of polyp resection.

干预措施: Standard polypectomy (Other)

Endocuff Vision Arm

Active Comparator

Endocuff Vision device mounted to the endoscope prior to the beginning of the procedure. Therefore EVD assisted polypectomy in case of polyp resection.

干预措施: Endocuff Vision assisted polypectomy (Device)

结局指标

主要结局

Polyp resection

时间窗: up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)]

Time of polyp resection will be measured using a stopwatch.

次要结局

  • Polyp detection(up to day 1)
  • Ileum intubation time(up to day 1)
  • Cecal intubation time(up to day 1)
  • Patient satisfaction(up to day 1)
  • Total procedure duration(up to day 1)
  • Complications(up to day 1)
  • Propofol dosage(up to day 1)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (2)

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