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临床试验/NCT01972451
NCT01972451已完成2 期

A Feasibility Randomised Controlled Trial (RCT) of Contrast Enhanced vs Non-enhanced Colonscopy in Index Bowel Cancer Screening to Reduce Bowel Cancer Mortality

Lisette Nixon2 个研究点 分布在 1 个国家目标入组 1,320 人开始时间: 2014年11月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
1,320
试验地点
2
主要终点
Procedure time and withdrawal time

研究概览

简要总结

The Bowel Cancer Screening program was implemented to address the important issue of prevention and early detection of bowel cancer. Results from the first few years of screening and previous smaller studies show that while in its current form it will save many lives, there continue to be polyps and cancers in the upper large bowel (right side) that may be difficult to detect. There is some evidence that these types of polyps (serrated polyps) may be at least partly responsible for cancers missed at the initial colonoscopy and have a faster rate of growth to cancer compared to conventional polyps (adenomas). We propose to examine participants undergoing screening colonoscopy with the addition of a contrast dye ( a safe food colouring agent base already used in various bowel camera procedures in standard clinical practice). This has been shown to improve detection of conventional polyps significantly even though it is considered by some to be more time consuming (possibly taking a few minutes longer) and requiring specific training to undertake. We hope to study the feasibility of undertaking these procedures to improve detection and removal of these polyps within the bowel screening program and potentially inform further studies to assess the impact of improved detection and consequent potentially reduced incidence of interval or missed bowel cancers in longer term follow up. Thus the main aims of this feasibility study are to assess if this type of procedure would be feasible to implement and acceptable to participants, colonoscopists and the screening program and also assess any additional time or costs involved to inform the question of if a larger study should then be undertaken to conclusively prove or disprove the merits of this approach in terms of health economics, cancer detection and survival.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All participants testing positive on Faecal Occult Blood Test (FOBT) in the screening program who are eligible and appropriate for an index screening colonoscopy will be offered participation in the study.
  • All participants attending for a one year surveillance colonoscopy if they have undergone an index screening colonoscopy as part of the study as per current guidelines for surveillance will also be offered inclusion

排除标准

  • Any participants not deemed fit for colonoscopy on the screening program or undergoing alternative investigation such as CT Pneumocolon or minimal prep CT scan as their index procedure instead.
  • Participants who have undergone previous colorectal surgery will be excluded from the study though their standard management in the screening program will continue unchanged.

研究组 & 干预措施

Colonoscopy without enhanced dye

Placebo Comparator

no enhanced dye

干预措施: Colonoscopy with enhanced dye (Procedure)

Colonoscopy with enhanced dye

Active Comparator

enhanced dye

干预措施: Colonoscopy with enhanced dye (Procedure)

结局指标

主要结局

Procedure time and withdrawal time

时间窗: 1 year

次要结局

  • Number of people attending the screening(1 year)

研究者

发起方
Lisette Nixon
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lisette Nixon

Senior Trial Manager

Cardiff University

研究点 (2)

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