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Full-spectrum Endoscopy in Colorectal Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812550
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Mª Henar Núñez Rodriguez, Hospital del Río Hortega

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: colonoscopy procedure Not Applicable

Detailed Description:

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Impact of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Controlled Trial
Study Start Date : May 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
full-spectrum colonoscopy
Colonoscopy is performed with a full-spectrum colonoscopy (330º angle of view)
Procedure: colonoscopy procedure
endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy

standar forward-viewing colonoscopy
Colonoscopy is performed with standar forward-viewing colonoscopy (170º angle of view)
Procedure: colonoscopy procedure
endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812550


Sponsors and Collaborators
Hospital del Río Hortega
Investigators
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Principal Investigator: Mª Henar Núñez Rodriguez, MD, PhD Hospital del Rio Hortega Valladolid, Spain
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mª Henar Núñez Rodriguez, Dra Mª Henar Núñez Rodriguez, Hospital del Río Hortega
ClinicalTrials.gov Identifier: NCT02812550    
Other Study ID Numbers: GRS 1073/A/15
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mª Henar Núñez Rodriguez, Hospital del Río Hortega:
full-spectrum endoscopy
polyp detection rate
colorectal cancer
colorectal screening
adenoma detection rate
endoscopic innovations
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases