NCT03041532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
692

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

January 25, 2017

Last Update Submit

February 16, 2020

Conditions

Colorectal NeoplasmsAdenoma Detection Rate

Keywords

retroflexion proximalcolorectal cancer screening programmeadenoma detection rateright colon

Outcome Measures

Primary Outcomes (1)

  • 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

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • Second look for right colon improve adenoma detection rate

    through study completion, an average of 1 year

  • Rate of retroflexion related adverse events

    through study completion, an average of 1 year

  • Rate of retroflexion proximal adverse events with a pediatric colonoscopy

    through study completion, an average of 1 year

  • Pre-procedure factors

    through study completion, an average of 1 year

Study Arms (2)

proximal retroflexion

EXPERIMENTAL

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

Procedure: Proximal retroflexionProcedure: Frontal view

frontal view of right colon

ACTIVE COMPARATOR

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

Procedure: Frontal view

Interventions

Proximal retroflexionPROCEDURE

The investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization

proximal retroflexion
Frontal viewPROCEDURE

The investigator explore twice right colon with frontal viewing

frontal view of right colonproximal retroflexion

Eligibility Criteria

Age50 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Mª Henar Núñez Rodriguez

    Hospital del Rio Hortega Valladolid, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator: Dra Mª Henar Núñez Rodriguez

Study Record Dates

First Submitted

January 25, 2017

First Posted

February 2, 2017

Study Start

October 1, 2017

Primary Completion

October 30, 2018

Study Completion

November 30, 2018

Last Updated

February 19, 2020

Record last verified: 2020-02

Locations

ES(1)