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Completed

NCT Number: NCT03041532

Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

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.

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Key information

Conditions

Colorectal Neoplasms Adenoma Detection Rate Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Proximal retroflexion

Procedure

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

Frontal view

Procedure

The investigator explore twice right colon with frontal viewing

Primary outcomes

  1. Proximal retroflexion improve adenoma detection rate in colorectal cancer screening

    Time frame: through 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 outcomes

  1. Second look for right colon improve adenoma detection rate

    Time frame: through study completion, an average of 1 year

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

  2. Rate of retroflexion related adverse events

    Time frame: through study completion, an average of 1 year

  3. Rate of retroflexion proximal adverse events with a pediatric colonoscopy

    Time frame: through study completion, an average of 1 year

  4. Pre-procedure factors

    Time frame: through 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

Sponsors and collaborators

Lead sponsor

Hospital del Rio Hortega

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 2, 2017
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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