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Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

Primary Purpose

Colorectal Neoplasms, Adenoma Detection Rate

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Proximal retroflexion
Frontal view
Sponsored by
Hospital del Río Hortega
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Neoplasms focused on measuring retroflexion proximal, colorectal cancer screening programme, adenoma detection rate, right colon

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital Universitario Rio Hortega

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

proximal retroflexion

frontal view of right colon

Arm Description

Procedure: The endoscopy explore right colon with frontal view and a second look with proximal retroflexion

Procedure: The endoscopy explore right colon with frontal view and frontal view

Outcomes

Primary Outcome Measures

Proximal retroflexion improve adenoma detection rate in colorectal cancer screening
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

Secondary Outcome Measures

Second look for right colon improve adenoma detection rate
Determine if a second look: retroflexion proximal or forward view improve adenoma detection rate
Rate of retroflexion related adverse events
Rate of retroflexion proximal adverse events with a pediatric colonoscopy
Pre-procedure factors
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

Full Information

First Posted
January 25, 2017
Last Updated
February 16, 2020
Sponsor
Hospital del Río Hortega
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1. Study Identification

Unique Protocol Identification Number
NCT03041532
Brief Title
Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme
Official Title
Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme: Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Río Hortega

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Adenoma Detection Rate
Keywords
retroflexion proximal, colorectal cancer screening programme, adenoma detection rate, right colon

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
692 (Actual)

8. Arms, Groups, and Interventions

Arm Title
proximal retroflexion
Arm Type
Experimental
Arm Description
Procedure: The endoscopy explore right colon with frontal view and a second look with proximal retroflexion
Arm Title
frontal view of right colon
Arm Type
Active Comparator
Arm Description
Procedure: The endoscopy explore right colon with frontal view and frontal view
Intervention Type
Procedure
Intervention Name(s)
Proximal retroflexion
Intervention Description
The investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization
Intervention Type
Procedure
Intervention Name(s)
Frontal view
Intervention Description
The investigator explore twice right colon with frontal viewing
Primary Outcome Measure Information:
Title
Proximal retroflexion improve adenoma detection rate in colorectal cancer screening
Description
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
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Second look for right colon improve adenoma detection rate
Description
Determine if a second look: retroflexion proximal or forward view improve adenoma detection rate
Time Frame
through study completion, an average of 1 year
Title
Rate of retroflexion related adverse events
Time Frame
through study completion, an average of 1 year
Title
Rate of retroflexion proximal adverse events with a pediatric colonoscopy
Time Frame
through study completion, an average of 1 year
Title
Pre-procedure factors
Description
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
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mª Henar Núñez Rodriguez
Organizational Affiliation
Hospital del Rio Hortega Valladolid, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Rio Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain

12. IPD Sharing Statement

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Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

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