Retroview Colonoscope for the Evaluation of Colon Mucosa Study (REVCOR)

January 27, 2015 updated by: Instituto Ecuatoriano de Enfermedades Digestivas

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 1301266
        • Instituto Ecuatoriano de Enfermedades Digestivas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

consecutive patients undergoing for colonoscopy at the Instituto Ecuatoriano de Enfermedades Digestivas

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
colonoscopy group
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.
Other Names:
  • Retro view colonoscopy
  • Retroflexion during colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 3 months
The safety was measured by the number of cases with bleeding or perforation
3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Withdrawal colonoscopy phase
Time Frame: 3 months
withdrawal colonoscopy phase time measured in minutes (excluding time taking in minutes in case of therapeutics)
3 months
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)
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of lesions
Time Frame: 3 months
number of lesions detected during the entire colonoscopy
3 months
Endoscopic Treatment
Time Frame: 3 months
number of endoscopic therapeutic procedures in retro vision during colonoscopy
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 5, 2014

First Submitted That Met QC Criteria

January 27, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Estimate)

February 2, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IECED 01-14-2014
  • IECED 2014-01 (Other Identifier: IECED 2014-01)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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