Study on Complications, EfficAcy and Costs of Large Polypectomy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,000
- Primary Endpoint
- complications of large polypectomy
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients undergoing large endoscopic polypectomy
Exclusion Criteria
- •pregnancy
- •incapacity to give informed consent
Outcomes
Primary Outcomes
complications of large polypectomy
Time Frame: 15 days
incidence of polypectomy-related adverse events
Secondary Outcomes
- costs of large polypectomy(15 days)
- efficacy of large polypectomy(6 months)
Investigators
Arnaldo Amato
MD
Valduce Hospital