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Completed

NCT Number: NCT02352233

Retroview Colonoscope for the Evaluation of Colon Mucosa Study

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.

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Key information

Conditions

Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Ecuatoriano de Enfermedades Digestivas

Guayaquil, Guayas, 1301266, Ecuador

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RETROVIEW colonoscope

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.

Other names: Retro view colonoscopy, Retroflexion during colonoscopy

Primary outcomes

  1. Safety

    Time frame: 3 months

    The safety was measured by the number of cases with bleeding or perforation

  2. Feasibility

    Time frame: 3 months

    The feasibility was measured determining the number of cases that was possible to perform a retro view by segments in the colon.

Secondary outcomes

  1. Withdrawal colonoscopy phase

    Time frame: 3 months

    withdrawal colonoscopy phase time measured in minutes (excluding time taking in minutes in case of therapeutics)

  2. Total procedure time

    Time frame: 3 months

    Total procedure time including retro view and forward view in minutes (excluding time taking in minutes in case of therapeutics)

Other outcomes

  1. Number of lesions

    Time frame: 3 months

    number of lesions detected during the entire colonoscopy

  2. Endoscopic Treatment

    Time frame: 3 months

    number of endoscopic therapeutic procedures in retro vision during colonoscopy

Sponsors and collaborators

Lead sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Other

Registry information

Official study title

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

Acronym: REVCOR

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 2, 2015
Registry last updated
Feb 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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