Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

• ClinicalTrials.gov Identifier: NCT03041532
• Recruitment Status: Completed
• First Posted: February 2, 2017
• Last Update Posted: February 19, 2020
• Sponsor: Hospital del Río Hortega
• Information provided by (Responsible Party): Mª Henar Núñez Rodriguez, Hospital del Río Hortega

Tracking Information

• First Submitted Date: January 25, 2017
• First Posted Date: February 2, 2017
• Last Update Posted Date: February 19, 2020
• Actual Study Start Date: October 1, 2017
• Actual Primary Completion Date: October 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Screening

Condition

• Colorectal Neoplasms
• Adenoma Detection Rate

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 16, 2020): 692
• Original Estimated Enrollment (submitted: February 1, 2017): 956
• Actual Study Completion Date: November 30, 2018
• Actual Primary Completion Date: October 30, 2018 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 69 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03041532
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Mª Henar Núñez Rodriguez, Hospital del Río Hortega
• Study Sponsor: Hospital del Río Hortega
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mª Henar Núñez Rodriguez; Hospital del Rio Hortega Valladolid, Spain

• PRS Account: Hospital del Río Hortega
• Verification Date: February 2020