Study on Complications, EfficAcy and Costs of Large Polypectomy (SCALP)

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 Overview

• Status: Unknown
• Conditions: Polypectomy

• Study Type: Observational
• Enrollment (Anticipated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Population undergoing large endoscopic polypectomy

Description

Inclusion Criteria:

• adult patients undergoing large endoscopic polypectomy

Exclusion Criteria:

• pregnancy
• incapacity to give informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
colonoscopy population

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications of large polypectomy	incidence of polypectomy-related adverse events	15 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Valduce Hospital

Publications and helpful links

General Publications

• Amato A, Radaelli F, Correale L, Di Giulio E, Buda A, Cennamo V, Fuccio L, Devani M, Tarantino O, Fiori G, De Nucci G, De Bellis M, Hassan C, Repici A; Bowell Group. Intra-procedural and delayed bleeding after resection of large colorectal lesions: The SCALP study. United European Gastroenterol J. 2019 Dec;7(10):1361-1372. doi: 10.1177/2050640619874176. Epub 2019 Sep 23.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: January 29, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Estimate): February 29, 2016
• Last Update Submitted That Met QC Criteria: February 23, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2016.2