Retroview Colonoscope for the Evaluation of Colon Mucosa Study

NCT ID: NCT02352233

Last Updated: 2015-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-04-30

Brief 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.

Detailed 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.

Conditions

Colonic Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

colonoscopy group

consecutive patients undergoing for colonoscopy for any formal indication. Patients were submitted to colonoscopy using RETROVIEW colonoscope

RETROVIEW colonoscope

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Retro view colonoscopy; Retroflexion during colonoscopy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Ecuatoriano de Enfermedades Digestivas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Robles-Medranda, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Ecuatoriano de Enfermedades Digestivas

Locations

Instituto Ecuatoriano de Enfermedades Digestivas

Guayaquil, Guayas, Ecuador

Countries

Ecuador

References

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.

Reference Type: BACKGROUND

PMID: 20018280 (View on PubMed)

Other Identifiers

IECED 2014-01

Identifier Type: OTHER

Identifier Source: secondary_id

IECED 01-14-2014

Identifier Type: -

Identifier Source: org_study_id