Full-spectrum Endoscopy in Colorectal Cancer Screening

Hospital del Rio Hortega249 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

249

Conditions

Colorectal Cancer

Interventions

colonoscopy procedurePROCEDURE

endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy

Eligibility

Sex: ALLMin age: 50 YearsMax age: 69 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: one week

Secondary Outcomes

time to caecal intubation in each group

time to reach appendicular orifice

Time frame: one week

total procedure time in each group

time since the begining of the procedure till is totally finish

Time frame: one week

Adverse events

Any inmediatly complication

Time frame: one week

advance adenoma rate in each group

10mm or greater in size, villous component or high grade dysplasia

Time frame: one week

polyp detection rate in right and left colon in each group

Time frame: one week

polyp retrieval rate in each group

proportion of resected polyps that were retrieved and sent for histologically analysis

Time frame: one week

caecal intubation rate in each group

proportion of all colonoscopic procedures in which the caecum, terminal ileum was reached

Time frame: one week

colonoscopy withdrawal time

Data from ClinicalTrials.gov

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