Retroview Colonoscope for the Evaluation of Colon Mucosa Study

Colonic Diseases Clinical Trial

— REVCOR  

Official title:

Pentax Retroview Colonoscope for the Evaluation of Colon Mucosa in Forward and Retro Viewing: a Safety and Feasibility Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352233
• Other study ID #: IECED 01-14-2014
• Secondary ID: IECED 2014-01
• Status: Completed
• Phase: N/A
• First received: August 5, 2014
• Last updated: January 27, 2015
• Start date: January 2014
• Est. completion date: April 2014

Study information

• Verified date: September 2014
• Source: Instituto Ecuatoriano de Enfermedades Digestivas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ecuador: Public Health Ministry
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• undergoing colonoscopy for colorectal neoplasia screening, for polyp surveillance, or for diagnostic workup including anemia, abdominal pain, constipation, abnormal imaging; and if they were able to understand and provide written consent for the procedure.

Exclusion Criteria:

• age <18; pregnancy, included history of colon resection, known inflammatory bowel disease, polyposis syndrome, radiation therapy to abdomen or pelvis, suspicion of chronic stricture potentially precluding complete colonoscopy, presence of diverticulitis or toxic megacolon, hemophilia and concurrent enrollment in another clinical investigation.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Diseases

Intervention

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.

Locations

Country	Name	City	State
Ecuador	Instituto Ecuatoriano de Enfermedades Digestivas	Guayaquil	Guayas

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Ecuatoriano de Enfermedades Digestivas

Country where clinical trial is conducted

Ecuador, 

References & Publications (1)

Waye JD, Heigh RI, Fleischer DE, Leighton JA, Gurudu S, Aldrich LB, Li J, Ramrakhiani S, Edmundowicz SA, Early DS, Jonnalagadda S, Bresalier RS, Kessler WR, Rex DK. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos). Gastrointest Endosc. 2010 Mar;71(3):551-6. doi: 10.1016/j.gie.2009.09.043. Epub 2009 Dec 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of lesions	number of lesions detected during the entire colonoscopy	3 months	Yes
Other	Endoscopic Treatment	number of endoscopic therapeutic procedures in retro vision during colonoscopy	3 months	Yes
Primary	Safety	The safety was measured by the number of cases with bleeding or perforation	3 months	Yes
Primary	Feasibility	The feasibility was measured determining the number of cases that was possible to perform a retro view by segments in the colon.	3 months	Yes
Secondary	Withdrawal colonoscopy phase	withdrawal colonoscopy phase time measured in minutes (excluding time taking in minutes in case of therapeutics)	3 months	Yes
Secondary	Total procedure time	Total procedure time including retro view and forward view in minutes (excluding time taking in minutes in case of therapeutics)	3 months	Yes