Resect and Discard Strategy in Clinical Practice
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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 |
- 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 ]
- 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 |
Consecutive adult outpatients undergoing colonoscopy for routine clinical indications
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 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 May 22, 2013