Full-spectrum Endoscopy in Colorectal Cancer Screening
Impact of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Controlled Trial
1 other identifier
interventional
249
0 countries
N/A
Brief Summary
The purpose of this study is to compare the adenoma detection rates of full-spectrum endoscopy versus standard forward-viewing colonoscopy in colorectal cancer screening programme.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started May 2015
Shorter than P25 for not_applicable colorectal-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 15, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedJune 24, 2016
June 1, 2016
1 year
June 15, 2016
June 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
adenoma detection rate in the two different colonoscopies
number of colonoscopies at wich one or more histologically confirmed adenomas were found divided by the total number of colonoscopies performed in the same time period.
one week
Secondary Outcomes (8)
time to caecal intubation in each group
one week
total procedure time in each group
one week
Adverse events
one week
advance adenoma rate in each group
one week
polyp detection rate in right and left colon in each group
one week
- +3 more secondary outcomes
Study Arms (2)
full-spectrum colonoscopy
OTHERColonoscopy is performed with a full-spectrum colonoscopy (330º angle of view)
standar forward-viewing colonoscopy
OTHERColonoscopy is performed with standar forward-viewing colonoscopy (170º angle of view)
Interventions
endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy
Eligibility Criteria
You may qualify if:
- patient referred for colorectal cancer screening with positive fecal inmunological test.
- Age between 50 and 69 years
You may not qualify if:
- history of colonic resection,
- high risk for colorectal cancer like family history of colorectal cancer o polyposis syndrome,
- inflammatory bowel disease,
- patients with lower gastrointestinal bleeding symptoms,
- acute diverticulitis,
- colonic strictures,
- poor bowel preparation (Boston scale less than 5 points)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Nunez-Rodriguez H, Diez-Redondo P, Perez-Miranda M, Gonzalez Sagrado M, Conde R, De la Serna C. Role of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Trial. J Clin Gastroenterol. 2019 Mar;53(3):191-196. doi: 10.1097/MCG.0000000000000975.
PMID: 29283904DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mª Henar Núñez Rodriguez, MD, PhD
Hospital del Rio Hortega Valladolid, Spain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dra Mª Henar Núñez Rodriguez
Study Record Dates
First Submitted
June 15, 2016
First Posted
June 24, 2016
Study Start
May 1, 2015
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
June 24, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share