Resect and Discard Strategy in Clinical Practice

This study has been completed.
Sponsor:
Information provided by:
Valduce Hospital
ClinicalTrials.gov Identifier:
NCT01462123
First received: October 27, 2011
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Endoscopic Assessment
Colonic Polyps
Endoscopic Surveillance
NBI
Other: endoscopic assessment of colonic polyps

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Valduce Hospital:

Primary Outcome Measures:
  • The primary outcome of the study was to assess the agreement between "endoscopy-" and "histology-determined" surveillance strategies after small adenoma resection. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sensitivity of the endoscopic assessment (WL coupled with NBI) of small (<10 mm) adenomas [ Designated as safety issue: No ]
  • operative characteristics for the diagnosis of diminutive (< 5 mm) adenomas [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • specificity of the endoscopic assessment [ Designated as safety issue: No ]
  • accuracy of the endoscopic assessment [ Designated as safety issue: No ]

Enrollment: 286
Study Start Date: February 2011
Groups/Cohorts Assigned Interventions
small polyps patients
Patients with one small polyps at colonoscopy
Other: endoscopic assessment of colonic polyps

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consecutive adult outpatients undergoing colonoscopy for routine clinical indications

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01462123

Locations
Italy
Valduce Hospital - Gastroenterology Department
Como, CO, Italy, 2100
Sponsors and Collaborators
Valduce Hospital
  More Information

No publications provided by Valduce Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01462123     History of Changes
Other Study ID Numbers: RD 2010
Study First Received: October 27, 2011
Last Updated: October 28, 2011
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 30, 2014