Full-spectrum Endoscopy in Colorectal Cancer Screening

Study Overview
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Brief Summary
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The purpose of this study is to compare the adenoma detection rates of full-spectrum endoscopy versus standard forward-viewing colonoscopy in colorectal cancer screening programme.

Detailed Description
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Colorectal cancer is the third most common neoplasia and the second leading cause of cancer death in West countries. Colonoscopy is the gold standard for prevention of colorectal cancer disease. Screening for colorectal cancer with biennial faecal occult blood testing is a widely used strategy followed by colonoscopy for those with a positive test. Colonoscopy identifies polyps during the procedure as well as polyp removal in order to prevent progression to cancer. Although, interval cancer appears after a colonoscopy because of 22-28% of polyp missed rates. Advanced Technology may improve adenoma detection rates so decrease interval cancer and reduce mortally. Full-spectrum endoscopy with 330º angle vision decrease adenoma miss rate in general population. The investigators conducted a randomized trial in patients from colorectal cancer screening programme (aged 50-69 years) after faecal immunological test positive. One arm the colonoscopy is performed with standard forward view colonoscopy (170º angle view) and the other arm is performed with full-spectrum endoscopy (EndoChoice) (330º angle view)

Official Title
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Impact of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Controlled Trial

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: colonoscopy procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient referred for colorectal cancer screening with positive fecal inmunological test. Age between 50 and 69 years Exclusion Criteria: history of colonic resection, high risk for colorectal cancer like family history of colorectal cancer o polyposis syndrome, inflammatory bowel disease, patients with lower gastrointestinal bleeding symptoms, acute diverticulitis, colonic strictures, poor bowel preparation (Boston scale less than 5 points)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: full-spectrum colonoscopy<br>Colonoscopy is performed with a full-spectrum colonoscopy (330º angle of view) | Procedure: colonoscopy procedure<br>* endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy<br>|
| Other: standar forward-viewing colonoscopy<br>Colonoscopy is performed with standar forward-viewing colonoscopy (170º angle of view) | Procedure: colonoscopy procedure<br>* endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adenoma detection rate in the two different colonoscopies | number of colonoscopies at wich one or more histologically confirmed adenomas were found divided by the total number of colonoscopies performed in the same time period. | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to caecal intubation in each group | time to reach appendicular orifice | one week | 
| total procedure time in each group | time since the begining of the procedure till is totally finish | one week | 
| Adverse events | Any inmediatly complication | one week | 
| advance adenoma rate in each group | 10mm or greater in size, villous component or high grade dysplasia | one week | 
| polyp detection rate in right and left colon in each group |  | one week | 
| polyp retrieval rate in each group | proportion of resected polyps that were retrieved and sent for histologically analysis | one week | 
| caecal intubation rate in each group | proportion of all colonoscopic procedures in which the caecum, terminal ileum was reached | one week | 
| colonoscopy withdrawal time | average time taken withdraw the colonoscope from the caecal pole to the anus. | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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full-spectrum endoscopy, polyp detection rate, colorectal cancer, colorectal screening, adenoma detection rate, endoscopic innovations