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临床试验/NCT02303756
NCT02303756已完成不适用

Colonic Capsule Endoscopy (CCE) for Screening of Neoplasm's

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2015年8月最近更新:
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
250
试验地点
2
主要终点
Identification of neoplasia

研究概览

简要总结

The primary aim is to evaluate the efficiency of capsule endoscopy (CCE) in in the detection of neoplasms compared to conventional colonoscopy in persons participating in the Danish screening program for colorectal cancer with a positive fecal occult blood with the colonoscopy being the gold standard.

详细描述

Participants will be recruited from the screening program, and are living on the main island of Funen. Persons with a positive FOBT who have been offered and have accepted a colonoscopy will be contacted by telephone and informed about the project by the project nurse.

The persons who accept participation and meet the inclusion criteria will be contacted by the study nurse for scheduling the capsule endoscopy according to the planned colonoscopy, which has to bee within 9-13 days after the result of the FOBT test.

The nurse will instruct the person to take the standard colon preparation 2 days before the colonoscopy, and stay from solid food until after the colonoscopy has been performed according to standard procedure. Thus the period with food-restrictions has to be extended by one day. A visit by the home services nurse the day before the colonoscopy will be arranged. The nurse will assist and supervise the intake of the video capsule and assists with the attachment of the monitor in a belt around the person's belly. Afterwards the questionnaire 1 (appendix 1) will be fulfilled by the patient with assistance from the nurse.

When the capsule has passed anus the monitoring equipment must be disarmed by the patient and stored according to the instructions. The patient will bring the recorder to the hospital the following day and deliver it to the study nurse, who will take care of data-transmission to the institute in Hamburg. After the colonoscopy and recovery period, the patient and the project nurse will fulfill the 2. questionnaire (appendix 2) and the colonoscopist will fulfill a standard report on the findings and treatment at colonoscopy (appendix 3), which will be added to the electronic database by the project secretary. The results form the colonoscopy will be the only information, that will be retrieved form the patients record.

Trained specialists in the Diagnostic Centre in Hamburg will perform the evaluation of the CCE and the data will be entered in a standard diagnostic report (appendix 4). The Diagnostic Centre will not have access to the results of the colonoscopy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Positive feaecal occult bleeding test at screening

排除标准

  • Previous gastrointestinal surgery except for appendectomy
  • Known inflammatory bowel disease including Chrohn's disease and ulcerative colitis
  • An ostomy
  • Symptoms on bowel obstruction (recurrent abdominal pain, constipation or vomiting within the last 3 months)
  • Vomiting in connection with the bowel emptying procedure

研究组 & 干预措施

Pillcam® COLON Capsule

Experimental

Detection of neoplastic lesions in colon and rectum compared to colonoscopy

干预措施: Pillcam® COLON Capsule (Device)

结局指标

主要结局

Identification of neoplasia

时间窗: One week after examination

Compared to colonoscopy

次要结局

  • Completion rate(24 hours)

研究者

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

Niels Qvist

Professor

Odense University Hospital

研究点 (2)

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