Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Neoplasms, Adenoma Detection Rate

Intervention / Treatment
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* Procedure: Proximal retroflexion
* Procedure: Frontal view


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenoma detection rate, retroflexion proximal, colorectal cancer screening programme, right colon