Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

February 16, 2020 updated by: Mª Henar Núñez Rodriguez, Hospital del Río Hortega

Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme: Randomized Trial

Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the Western world. The decrease in incidence and mortality by CRC in the population undergoing screening has been observed. Colonoscopy is the recommended method for detecting tumors in early stages, as well as identifying and resecting adenomatous polyps, which are the precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does not prevent right colon lesions in the same way as the left colon lesions, with most of the interval cancers located in the right colon. Studies published so far show an increase in the adenomas detection rate (ADT) in the right colon in the second visualization of this segment and an increase between 2 and 10% if this second examination is performed with the proximal retroflexion maneuver.Retroflexion is a safe maneuver in expert endoscopists. The aim of our study is to evaluate the ADT in the right colon by means of a second visualization by performing proximal retroflexion or second frontal visualization at random in the CCR screening population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

692

Phase

  • Not Applicable

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

  • Spain
      • Valladolid, Spain, 47012
        • Hospital Universitario Rio Hortega

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

50 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects participating in the Colorectal cancer Screening program with faecal immunological test > 100ng / ml.
  • Ages between 50-69 years.
  • Adequate preparation according to the Boston scale: in right colon (score> 2 in this section)
  • Informed consent.

Exclusion Criteria:

  • Refusal to give informed consent.
  • Subjects with elevated colorectal cancer risk due to family history or inherited diseases of polyposis or inflammatory bowel disease
  • Symptomatic subjects.
  • Diverticulitis, inflammatory bowel disease or colonic stenosis during the exploration
  • Inadequate preparation according to Boston cleanliness scale (score ≤ 2 in right colon)

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: proximal retroflexion
Procedure: The endoscopy explore right colon with frontal view and a second look with proximal retroflexion
Procedure: Proximal retroflexion
The investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization
Procedure: Frontal view
The investigator explore twice right colon with frontal viewing
Active Comparator: frontal view of right colon
Procedure: The endoscopy explore right colon with frontal view and frontal view
Procedure: Frontal view
The investigator explore twice right colon with frontal viewing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proximal retroflexion improve adenoma detection rate in colorectal cancer screening
Time Frame: through study completion, an average of 1 year
Determine whether to perform retroflexion proximal improves adenoma detection rate in the right colon versus forward vision in population screening colorectal cancer with medium risk with immune blood test positive stool
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Second look for right colon improve adenoma detection rate
Time Frame: through study completion, an average of 1 year
Determine if a second look: retroflexion proximal or forward view improve adenoma detection rate
through study completion, an average of 1 year
Rate of retroflexion related adverse events
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Rate of retroflexion proximal adverse events with a pediatric colonoscopy
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Pre-procedure factors
Time Frame: through study completion, an average of 1 year
To analyze pre-procedure factors that may influence the prevalence of precursor lesions in the colon: age, sex, race, alcohol, smoking habit and the value of SOH, in which more detailed explorations should be performed using proximal retroflexion
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Hospital del Río Hortega

Investigators

  • Principal Investigator: Mª Henar Núñez Rodriguez, Hospital del Rio Hortega Valladolid, Spain

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 (Actual)

October 1, 2017

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

January 25, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 2, 2017

Study Record Updates

Last Update Posted (Actual)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 16, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC 62/16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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