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Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

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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

Tracking Information
First Submitted Date  ICMJE January 25, 2017
First Posted Date  ICMJE February 2, 2017
Last Update Posted Date February 19, 2020
Actual Study Start Date  ICMJE October 1, 2017
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
  • 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
  • Rate of retroflexion related adverse events [ Time Frame: through study completion, an average of 1 year ]
  • Rate of retroflexion proximal adverse events with a pediatric colonoscopy [ Time Frame: through study completion, an average of 1 year ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme
Official Title  ICMJE Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme: Randomized Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Condition  ICMJE
  • Colorectal Neoplasms
  • Adenoma Detection Rate
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: proximal retroflexion
    Procedure: The endoscopy explore right colon with frontal view and a second look with proximal retroflexion
    Interventions:
    • Procedure: Proximal retroflexion
    • Procedure: Frontal view
  • Active Comparator: frontal view of right colon
    Procedure: The endoscopy explore right colon with frontal view and frontal view
    Intervention: Procedure: Frontal view
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2020)
692
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2017)
956
Actual Study Completion Date  ICMJE November 30, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03041532
Other Study ID Numbers  ICMJE CEIC 62/16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mª Henar Núñez Rodriguez, Hospital del Río Hortega
Study Sponsor  ICMJE Hospital del Río Hortega
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mª Henar Núñez Rodriguez Hospital del Rio Hortega Valladolid, Spain
PRS Account Hospital del Río Hortega
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP