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OpenTrials
Completed

NCT Number: NCT01462123

Resect and Discard Strategy in Clinical Practice

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.

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Key information

Conditions

Endoscopic Assessment Colonic Polyps Endoscopic Surveillance Intestinal Polyps NBI Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Valduce Hospital - Gastroenterology Department

Como, CO, 2100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

endoscopic assessment of colonic polyps

Other

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

  1. sensitivity of the endoscopic assessment (WL coupled with NBI) of small (<10 mm) adenomas

  2. operative characteristics for the diagnosis of diminutive (< 5 mm) adenomas

  3. 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

  4. specificity of the endoscopic assessment

  5. accuracy of the endoscopic assessment

Sponsors and collaborators

Lead sponsor

Valduce Hospital

Other

Registry information

Important dates

Study start
2011
First posted
Oct 31, 2011
Registry last updated
Oct 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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