France is among the countries with a high incidence of colorectal cancer. The prognosis associated with colorectal cancer is related to the development stage of the disease at diagnosis. Thus, when the cancer is detected and treated at an early stage, the survival rate at 5 years was 90%. It is therefore a major issue of screening is widespread in France since the end of 2008. This screening is based on a two step strategy: 1) the occult blood in the stool (FOBT) and if positive 2) the realization of an optical colonoscopy examination currently regarded as the evaluation procedure colon reference. But as part of this organized screening, 13% of those with a positive FOBT ultimately refuse to have an optical colonoscopy. Under the refusal, virtual colonoscopy may be proposed as an alternative according to the recommendations of the National Health Authority in 2010. But it has never been assessed as part of organized screening. Similarly another alternative is recently developed colic capsule that benefits of development in recent years of the capsule for the small intestine which has become the gold standard for diagnosis of most diseases of the small intestine (bleeding occult, diagnosis of unknown colitis...). Therefore the study proposes virtual colonoscopy or colon capsule for people with a positive FOBT as part of organized screening and did not realize optical colonoscopy after the usual procedure and complete recovery. This study aims to answer the question of the place of colic capsule as part of organized screening. An economic component is integrated to assess, in terms of health insurance, the cost associated with these two exams, and compare them to the cost of optical colonoscopy. The proposed study is an observational study of impact of an alternative screening strategy for colorectal cancer whose primary objective is to compare the rate of acceptance of virtual colonoscopy and colon capsule in patients refusing optical colonoscopy.
Study Type
OBSERVATIONAL
Enrollment
664
Hopsices Civils de Lyon
Lyon, France
Acceptance rate of colonic capsule versus virtual colonoscopy.
Acceptance is defined by the fact that a person having made an appointment for one of the two exams and he went to the review
Time frame: A period of three months after sending the letter of invitation to an alternative to optical colonoscopy is left to the person.
Success rate of virtual colonoscopy and colon capsule: full review rate of colonic mucosa.
Time frame: 6 months
Failure rate of examinations by cause
Percentage of bad colic preparations, percentage against-indications, complication rate, percentage capsules have not been to the end of the colon, percentage of other causes (eg. technical ...)
Time frame: 6 months
Diagnostic performance of virtual colonoscopy and colon capsule
Percentage of patients with suspected colorectal neoplastic lesions
Time frame: 6 months
Achievement rate of optical colonoscopy if a lesion is found, either by virtual colonoscopy, or by colonic capsule
Percentage of patients who achieve an optical colonoscopy after suspected neoplastic colorectal lesion
Time frame: 6 months
Sensitivity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps
Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter
Time frame: 6 months
Specificity of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps
Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter
Time frame: 6 months
Positive and negative predictive values of virtual colonoscopy and colonic capsule for the diagnosis of cancer, significant additional colorectal polyps, or other polyps
Significant additional colorectal polyps is at least a polyp 6 mm minimum diameter or more than three polyps of any diameter
Time frame: 6 months
Percentage of cancers diagnosed through virtual colonoscopy or colonic capsule
Time frame: 6 months
Additional costs generated by the implementation of a complementary action of screening for patients with a positive FOBT and did not realize optical colonoscopy
The costs taken into account will be the direct medical costs of two exams, as well as non-medical direct costs: 1) Letters of invitation to perform any of the tests, 2) Examination conducted (colon capsule or virtual colonoscopy), 3) Letters of Transmittal results
Time frame: 6 months
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