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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

Locations

Spain

Hospital Universitario Rio Hortega

Valladolid, Spain, 47012

Sponsors and Collaborators

Hospital del Río Hortega

Investigators

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

More Information

• 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
• Last Update Posted: February 19, 2020
• Last Verified: February 2020

• 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:

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