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Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

Not Applicable
Completed
Conditions
Colorectal Neoplasms
Adenoma Detection Rate
Interventions
Procedure: Proximal retroflexion
Procedure: Frontal view
Registration Number
NCT03041532
Lead Sponsor
Hospital del Río Hortega
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
692
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
proximal retroflexionProximal retroflexionProcedure: The endoscopy explore right colon with frontal view and a second look with proximal retroflexion
frontal view of right colonFrontal viewProcedure: The endoscopy explore right colon with frontal view and frontal view
proximal retroflexionFrontal viewProcedure: The endoscopy explore right colon with frontal view and a second look with proximal retroflexion
Primary Outcome Measures
NameTimeMethod
Proximal retroflexion improve adenoma detection rate in colorectal cancer screeningthrough 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

Secondary Outcome Measures
NameTimeMethod
Second look for right colon improve adenoma detection ratethrough study completion, an average of 1 year

Determine if a second look: retroflexion proximal or forward view improve adenoma detection rate

Rate of retroflexion related adverse eventsthrough study completion, an average of 1 year
Rate of retroflexion proximal adverse events with a pediatric colonoscopythrough study completion, an average of 1 year
Pre-procedure factorsthrough 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

Trial Locations

Locations (1)

Hospital Universitario Rio Hortega

🇪🇸

Valladolid, Spain

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