Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

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: Colorectal Neoplasms; Adenoma Detection Rate
• Intervention / Treatment: Procedure: Proximal retroflexion; Procedure: Frontal view

• Study Type: Interventional
• Enrollment (Actual): 692
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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		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	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

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

Study record dates

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: adenoma detection rate; right colon; retroflexion proximal; colorectal cancer screening programme
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• 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