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N/A N=1,148 Randomized Screening

Does Cap Assisted Colonoscopy Improve Detection of Adenomatous Polyps? (CAP Trial)

Adenomatous Polyps

Enrolled (actual)
1,148
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Mean Number of Adenomas — 0.82; 0.89 adenoma per patient

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Colonoscopy Cap (Device)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
White River Junction Veterans Affairs Medical Center
Primary completion
May 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Number of Adenomas
0.82; 0.89
SECONDARY
Adenoma Detection Rate
219; 235
SECONDARY
Advanced Adenoma Detection Rate
49; 55
SECONDARY
Quality of Bowel Preparation
518; 502
SECONDARY
Withdrawal Time
8.9; 8.4
SECONDARY
Ease of Terminal Ileum Intubation
435; 473
SECONDARY
Real Time Prediction of Polyp Histology
246; 281

Summary

Effectiveness of screening colonoscopy in cancer prevention relies on the detection and removal of adenomatous polyps. However, a substantial rate of adenomas is missed during a colonoscopy. It has been estimated that two thirds of missed adenomas are located on the proximal aspect of colonic folds. Attaching a transparent cap to the tip of a colonoscope may allow examination of the proximal aspect of colonic folds, and some early studies have suggested an increased polyp and adenoma detection using this technology. However, the studies have in part substantial methodological limitations (e.g. missing polyp histology, single endoscopist study, polyps not removed at the time of detection). Therefore, at this point it is unclear whether cap assisted colonoscopy may improve adenoma detection. The objective of this study is to evaluate whether cap assisted colonoscopy improves adenoma detection. The investigators propose a two-center multiple endoscopists randomized controlled trial. Patients will be randomized to cap assisted colonoscopy or standard high definition white light colonoscopy. The cap is a 4mm commercially available transparent cap that is attached to the tip of the colonoscopy. Primary outcome measure is the adenoma detection rate (mean number of adenoma per patient). The investigators will assess and adjust for possible variables that can affect adenoma detection, including withdrawal time and quality of colon preparation. As a secondary outcome of interest the investigators will evaluate a possible learning curve effect among all endoscopists (a minimum of six) new to this method. In addition the investigators will evaluate whether cap assisted endoscopy improves real time prediction of polyp histology.

Eligibility Criteria

Inclusion Criteria

  • Any patient ≥ 50 years old and 3)
  • Patients on coumadin at the time of the procedure or with a coagulopathy and an elevated INR ≥ 1.5, or platelets < 50
  • Patients who do not consent
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01935180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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