An interventional study of colonoscopy procedure in Colorectal Cancer, sponsored by Hospital del Rio Hortega. Completed. Open to participants aged 50 Years to 69 Years. Per ClinicalTrials.gov, last updated 2016-06-24.
Sponsored by Hospital del Rio Hortega · Not applicable, Interventional, and 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.
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)
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 249 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Hospital del Rio Hortega is the lead sponsor of 26 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Colonoscopy is performed with a full-spectrum colonoscopy (330º angle of view)
Procedure: colonoscopy procedure
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
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
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
average time taken withdraw the colonoscope from the caecal pole to the anus.
Time frame: one week
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Hospital del Rio Hortega