An observational study in Colonic Diseases, sponsored by Instituto Ecuatoriano de Enfermedades Digestivas. Completed at 1 site in Ecuador. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-02-02.
Sponsored by Instituto Ecuatoriano de Enfermedades Digestivas · Observational
Colonoscopy is the "gold standard" technique for diagnosis and treatment of colonic lesions. Moreover, high definition colonoscopes (HD) associated to digital chromoendoscopy had shown better results regarding adenoma and polyps detection when compared to standard non HD scopes. However, evidence shows that during standard colonoscopy many lesions could be missed, including polyps, cancer and other kind of lesions. This could be correlated to many factors and recently reports show evidence that lesions behind the folds could be missed because the limitation of a forward view examination. Until know, a new auxiliary imaging device called "Third Eye Retroscope" had demonstrated more lesions detection during colonoscopy using a retro view, but with some limitations as absence of HD vision, the need of additional equipment and the fact the device occupies the accessory channel, limiting therapeutic efficiency. Recently a new HD colonoscope called "RETROVIEW" (PENTAX Medical) has been developed. It permits visualization of colonic mucosa in forward view, in retroflex view and allows for performance of diagnostic and therapeutics in a single colonoscope.
Primary outcome:
To determine the safety and feasibility of the retro view during colonoscopy using RETROVIEW colonoscope. Safety was measured by the number of bleeding or perforation rates as adverse event during the procedure. Feasibility was measured by the number of cases that is possible to achieve a retroflexion in the colon Secondary outcome: withdrawal phase time and total procedure time.
147 studies on the registry are indexed under Colonic Diseases; 23 are open to participants now.
This study's enrollment of 48 is below the median of 165 across 51 observational studies indexed under Colonic Diseases.
Browse Colonic Diseases studies →Instituto Ecuatoriano de Enfermedades Digestivas is the lead sponsor of 39 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
consecutive patients undergoing for colonoscopy at the Instituto Ecuatoriano de Enfermedades Digestivas
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Exclusion Criteria:
consecutive patients undergoing for colonoscopy for any formal indication. Patients were submitted to colonoscopy using RETROVIEW colonoscope
Procedure: RETROVIEW colonoscope
withdrawal in retro vision and forward vision was performed by segments (right, transverse, left, sigmoid colon and rectum). Retroflexed therapeutics procedures were executed when needed.
Also known as: Retro view colonoscopy, Retroflexion during colonoscopy
Safety
The safety was measured by the number of cases with bleeding or perforation
Time frame: 3 months
Feasibility
The feasibility was measured determining the number of cases that was possible to perform a retro view by segments in the colon.
Time frame: 3 months
Withdrawal colonoscopy phase
withdrawal colonoscopy phase time measured in minutes (excluding time taking in minutes in case of therapeutics)
Time frame: 3 months
Total procedure time
Total procedure time including retro view and forward view in minutes (excluding time taking in minutes in case of therapeutics)
Time frame: 3 months
Number of lesions
number of lesions detected during the entire colonoscopy
Time frame: 3 months
Endoscopic Treatment
number of endoscopic therapeutic procedures in retro vision during colonoscopy
Time frame: 3 months
The record gives a start of Jan 2014, a primary completion of Mar 2014 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Instituto Ecuatoriano de Enfermedades Digestivas