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Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041532
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Mª Henar Núñez Rodriguez, 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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Adenoma Detection Rate Procedure: Proximal retroflexion Procedure: Frontal view Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 692 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme: Randomized Trial
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041532


Locations
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Spain
Hospital Universitario Rio Hortega
Valladolid, Spain, 47012
Sponsors and Collaborators
Hospital del Río Hortega
Investigators
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Principal Investigator: Mª Henar Núñez Rodriguez Hospital del Rio Hortega Valladolid, Spain
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Responsible Party: Mª Henar Núñez Rodriguez, Principal Investigator: Dra Mª Henar Núñez Rodriguez, Hospital del Río Hortega
ClinicalTrials.gov Identifier: NCT03041532    
Other Study ID Numbers: CEIC 62/16
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mª Henar Núñez Rodriguez, Hospital del Río Hortega:
retroflexion proximal
colorectal cancer screening programme
adenoma detection rate
right colon
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type