Resect and Discard Strategy in Clinical Practice

NCT01462123 | Completed

• 1 other identifier: RD 2010
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Assessment; Colonic Polyps; Endoscopic Surveillance; NBI

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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

Study Arms (1)

small polyps patients

Patients with one small polyps at colonoscopy

Other: endoscopic assessment of colonic polyps

Interventions

endoscopic assessment of colonic polyps OTHER

small polyps patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive adult outpatients undergoing colonoscopy for routine clinical indications

You may qualify if:

• consecutive adult outpatients undergoing colonoscopy for routine clinical indications

You may not qualify if:

• 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.

Sponsors & Collaborators

• Valduce Hospital: lead

Study Sites (1)

Valduce Hospital - Gastroenterology Department

Como, CO, 2100, Italy

Location

Related Publications (1)

• Paggi S, Rondonotti E, Amato A, Terruzzi V, Imperiali G, Mandelli G, Terreni N, Lenoci N, Spinzi G, Radaelli F. Resect and discard strategy in clinical practice: a prospective cohort study. Endoscopy. 2012 Oct;44(10):899-904. doi: 10.1055/s-0032-1309891. Epub 2012 Aug 2.

  PMID: 22859259 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: October 31, 2011
• Study Start: February 1, 2011
• Last Updated: October 31, 2011

Record last verified: 2011-10

Locations

IT (1)