Study on Complications, EfficAcy and Costs of Large Polypectomy

• Conditions: Polypectomy

• Registration Number: NCT02694120
• Lead Sponsor: Valduce Hospital

Brief Summary

Colonoscopy has been shown to reduce the incidence and mortality of colorectal cancer, through the recognition and removal of pre-cancerous lesions, which in most cases evolve with a sequence that goes through formation of high-grade dysplasia (HGD).

The probability of HGD increases with the increase of the lesion of the polyp itself. Lesions\> 2 cm are present in 1% of colonoscopy screening. The resection of these lesions presents a greater technical difficulty and consequently a decrease in the efficiency. The rate of incomplete resection reported in the literature reaches 10% while that of recurrence / residual adenoma 16.4 / 31.7%.

The aim of the study SCALP is to evaluate the incidence of complications, efficacy and cost of endoscopic resection of colic lesions\> 2cm in a setting of clinical practice in an unselected population

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-29
• Status Verified: 2016-02
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-23
• Last Update Submitted: 2016-02-23
• Study First Posted: 2016-02-29
• Last Update Posted: 2016-02-29
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• adult patients undergoing large endoscopic polypectomy

Exclusion Criteria

• pregnancy
• incapacity to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
complications of large polypectomy	15 days	incidence of polypectomy-related adverse events

Secondary Outcome Measures

Name	Time	Method
costs of large polypectomy	15 days	assessment of the average cost per procedure, including devices and staff costs
efficacy of large polypectomy	6 months	assessment of residual adenoma at follow-up