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临床试验/NCT00590434
NCT00590434已完成不适用

The Yield and Safety of Screening and Surveillance Colonoscopy in Elderly Patients (> 80 Years)

Midwest Biomedical Research Foundation1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2006年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
169
试验地点
1
主要终点
Proportion of elderly patients (>80 yrs) with colorectal neoplasia

研究概览

简要总结

The aim of the study is to study the risk of colorectal cancer and polyps in people older than 80 years compared to the younger age group. The researchers hypothesized that colonoscopy in older people is likely to have more complications without detection of a significant number of large polyps and cancer.

详细描述

Background and Clinical Significance:

Colorectal cancer continues to carry a significant burden of morbidity and mortality into the twenty-first century, despite the availability of multiple screening modalities. It is estimated that approximately 150,000 new cases of CRC will be diagnosed and over 50,000 people will die of CRC in 2006 (1). Current options for screening for CRC include fecal occult-blood testing, flexible sigmoidoscopy, double contrast barium enema, and colonoscopy. While no randomized controlled trials have shown a mortality benefit with screening colonoscopy, it has become the preferred method of both screening and surveillance of polyps because of the ability to visualize the entire colon in addition to having the ability to remove polyps. This procedure does associated risks including perforation and bleeding after polypectomy. Other major complications have also been reported, including MI and CVA.

Although guidelines exist for colorectal cancer screening and surveillance of polyps, they do not define the upper age limit to which these practices should be carried out (2,3). No clear data is available on the effect of this procedure on life expectancy after the age of 80. Also, the country has limited resources and screening colonoscopy may be offered to those who are most likely to benefit. Based on these facts, there is a real need to quantify the prevalence of colon neoplasia in this age group to guide primary care physicians as well as gastroenterologists in offering screening and surveillance colonoscopy to this age group. Like many medical decisions, cancer screening requires weighing quantitative information, such as risk of cancer death and likelihood of beneficial and adverse screening outcomes, as well as qualitative factors, such as individual patients' values and preferences. In fact, patients with life expectancies of less than 5 years are unlikely to derive any survival benefit from cancer screening. There is also potential for harm from screening procedures. Some of the greatest harms of screening occur by detecting cancers that would never have become clinically significant. This becomes more likely as life expectancy decreases.

As the population ages and life expectancy continues to increase, more elderly patients will be referred for colonoscopy. What is the utility of performing colonoscopy in these asymptomatic patients, and is it safe? Few studies have examined this question adequately. What follows is a brief review of published data in regards to yield and safety of colonoscopy in the elderly.

Yield:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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 patients presenting for colonoscopy after 1997
  • Age 80 or older for the study group
  • Age 50-79 for the control group
  • Indications for colonoscopy:
  • Average risk screening for CRC
  • Surveillance of polyps (tubular adenomas)

排除标准

  • Any colonoscopy done for symptoms (abdominal pain, weight loss, hematochezia, occult blood in stool, etc) or signs (iron deficiency anemia)
  • Patients who are not average risk based on family history of CRC
  • Diagnosis of ulcerative colitis or Crohn's Disease
  • History of CRC
  • Exams that were not completed to the cecum (except in cases of obstructing masses found to be neoplastic) or poor bowel preparation limiting visualization of the mucosa

结局指标

主要结局

Proportion of elderly patients (>80 yrs) with colorectal neoplasia

时间窗: 2 years

proportion of patients with complications including perforation, bleeding, MI or CVA within 24 hours of colonoscopy in >80 vs. <80 agr group

时间窗: 2 years

次要结局

  • Five year disease free survival and five year mortality rates after the diagnosis of colon cancer in older (>80 yrs) vs. younger group (<80 yrs)(2 years)

研究者

发起方
Midwest Biomedical Research Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ajay Bansal

Principal Investigator, Staff Physician

Midwest Biomedical Research Foundation

研究点 (1)

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