Clinical trial NCT03041532: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Adenoma Detection Rate
Keywords: retroflexion proximal
colorectal cancer screening programme
adenoma detection rate
right colon
Lead sponsor: Hospital del Rio Hortega
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 692
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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)

Primary outcomes:
measure: Proximal retroflexion improve adenoma detection rate in colorectal cancer screening
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Second look for right colon improve adenoma detection rate
timeFrame: through study completion, an average of 1 year
measure: Rate of retroflexion related adverse events
timeFrame: through study completion, an average of 1 year
measure: Rate of retroflexion proximal adverse events with a pediatric colonoscopy
timeFrame: through study completion, an average of 1 year
measure: Pre-procedure factors
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
Study officials:
affiliation: Hospital del Rio Hortega Valladolid, Spain
name: Mª Henar Núñez Rodriguez
role: PRINCIPAL_INVESTIGATOR
References: