Resect and Discard Strategy in Clinical Practice

Completed

• Conditions: Endoscopic Assessment; Colonic Polyps; Endoscopic Surveillance; NBI
• Interventions: Other: endoscopic assessment of colonic polyps

• Registration Number: NCT01462123
• Lead Sponsor: Valduce Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Status Verified: 2011-10
• Study First Submitted: 2011-10-27
• Study First Submitted QC: 2011-10-28
• Last Update Submitted: 2011-10-28
• Study First Posted: 2011-10-31
• Last Update Posted: 2011-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
small polyps patients	endoscopic assessment of colonic polyps	Patients with one small polyps at colonoscopy

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study was to assess the agreement between "endoscopy-" and "histology-determined" surveillance strategies after small adenoma resection.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Valduce Hospital - Gastroenterology Department; 🇮🇹 Como, CO, Italy