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Completed

NCT Number: NCT02812550

Full-spectrum Endoscopy in Colorectal Cancer Screening

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.

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

colonoscopy procedure

Procedure

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

Primary outcomes

  1. adenoma detection rate in the two different colonoscopies

    Time frame: one week

    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.

Secondary outcomes

  1. time to caecal intubation in each group

    Time frame: one week

    time to reach appendicular orifice

  2. total procedure time in each group

    Time frame: one week

    time since the begining of the procedure till is totally finish

  3. Adverse events

    Time frame: one week

    Any inmediatly complication

  4. advance adenoma rate in each group

    Time frame: one week

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

  5. polyp detection rate in right and left colon in each group

    Time frame: one week

  6. polyp retrieval rate in each group

    Time frame: one week

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

  7. caecal intubation rate in each group

    Time frame: one week

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

  8. colonoscopy withdrawal time

    Time frame: one week

    average time taken withdraw the colonoscope from the caecal pole to the anus.

Sponsors and collaborators

Lead sponsor

Hospital del Rio Hortega

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 24, 2016
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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