Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041532
• Other study ID #: CEIC 62/16
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: February 2020
• Source: Hospital del Río Hortega
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 692
• Est. completion date: November 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adenoma
• Adenoma Detection Rate
• Colorectal Neoplasms

Intervention

Procedure:
• Proximal retroflexion
The investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization
• Frontal view
The investigator explore twice right colon with frontal viewing

Locations

Country	Name	City	State
Spain	Hospital Universitario Rio Hortega	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital del Río Hortega

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proximal retroflexion improve adenoma detection rate in colorectal cancer screening	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	through study completion, an average of 1 year
Secondary	Second look for right colon improve adenoma detection rate	Determine if a second look: retroflexion proximal or forward view improve adenoma detection rate	through study completion, an average of 1 year
Secondary	Rate of retroflexion related adverse events		through study completion, an average of 1 year
Secondary	Rate of retroflexion proximal adverse events with a pediatric colonoscopy		through study completion, an average of 1 year
Secondary	Pre-procedure factors	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	through study completion, an average of 1 year