Resect and Discard Strategy in Clinical Practice

Colonic Polyps Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462123
• Other study ID #: RD 2010
• Status: Completed
• Phase: N/A
• First received: October 27, 2011
• Last updated: October 28, 2011
• Start date: February 2011

Study information

• Verified date: October 2011
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Polyps
• Endoscopic Assessment
• Endoscopic Surveillance
• NBI

Intervention

Other:
• endoscopic assessment of colonic polyps

Locations

Country	Name	City	State
Italy	Valduce Hospital - Gastroenterology Department	Como	CO

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome of the study was to assess the agreement between "endoscopy-" and "histology-determined" surveillance strategies after small adenoma resection.			No
Secondary	sensitivity of the endoscopic assessment (WL coupled with NBI) of small (<10 mm) adenomas			No
Secondary	operative characteristics for the diagnosis of diminutive (< 5 mm) adenomas			No
Secondary	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			No
Secondary	specificity of the endoscopic assessment			No
Secondary	accuracy of the endoscopic assessment			No