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Resect and Discard Strategy in Clinical Practice

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01462123
Enrollment
286
Registered
2011-10-31
Start date
2011-02-28
Completion date
Unknown
Last updated
2011-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyps, Endoscopic Assessment, Endoscopic Surveillance, NBI

Brief summary

Nowadays, post-polypectomy surveillance intervals are determined by combining endoscopic and pathologic data. Real-time imaging technologies, have shown promising results in discriminating adenomatous from non-adenomatous polyps. The resect and discard strategy for small polyps (based on real-time assessment of the histology and on the endoscopic resection without pathological examination) has been shown to be cost-effective in simulation models. No data exist about the impact of this strategy in clinical practice. The aim of present study was to assess whether the systematic use, in the everyday clinical practice, of the resect and discard strategy allows to correctly manage patients with small colonic polyps.

Interventions

OTHERendoscopic assessment of colonic polyps

Sponsors

Valduce Hospital
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* consecutive adult outpatients undergoing colonoscopy for routine clinical indications

Exclusion criteria

* surveillance interval was not necessarily directed by endoscopic findings (history of colorectal cancer, inflammatory bowel disease, hereditary polyposis syndromes, hereditary non-polyposis colorectal cancer) * colonoscopy was performed without NBI technology * at least one lesion \> 10 mm or \< 10 mm but with morphologic features suspect for malignancy (depressed or ulcerated lesions) was detected * bowel preparation was inadequate * caecal intubation was not accomplished * polyps could not be resected for concomitant anticoagulation treatment, 7) polyps were resected but not retrieved for pathology.

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study was to assess the agreement between endoscopy- and histology-determined surveillance strategies after small adenoma resection.

Secondary

MeasureTime frame
sensitivity of the endoscopic assessment (WL coupled with NBI) of small (<10 mm) adenomas
operative characteristics for the diagnosis of diminutive (< 5 mm) adenomas
the feasibility of non histologic evaluation, represented by the proportion of polyps in which a in-vivo diagnosis of adenoma can be made with high confidence
specificity of the endoscopic assessment
accuracy of the endoscopic assessment

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026