Study on Complications, EfficAcy and Costs of Large Polypectomy

Polypectomy Clinical Trial

— SCALP  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02694120
• Other study ID #: 2016.2
• Status: Not yet recruiting
• Phase: N/A
• First received: January 29, 2016
• Last updated: February 23, 2016
• Start date: February 2016

Study information

• Verified date: February 2016
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients undergoing large endoscopic polypectomy

Exclusion Criteria:

• pregnancy

• incapacity to give informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Polypectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications of large polypectomy	incidence of polypectomy-related adverse events	15 days	No
Secondary	costs of large polypectomy	assessment of the average cost per procedure, including devices and staff costs	15 days	No
Secondary	efficacy of large polypectomy	assessment of residual adenoma at follow-up	6 months	No