NCT02694120

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

February 29, 2016

Status Verified

February 1, 2016

Enrollment Period

5 months

First QC Date

January 29, 2016

Last Update Submit

February 23, 2016

Conditions

Polypectomy

Outcome Measures

Primary Outcomes (1)

  • complications of large polypectomy

    incidence of polypectomy-related adverse events

    15 days

Secondary Outcomes (2)

  • costs of large polypectomy

    15 days

  • efficacy of large polypectomy

    6 months

Study Arms (1)

colonoscopy population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population undergoing large endoscopic polypectomy

You may qualify if:

  • adult patients undergoing large endoscopic polypectomy

You may not qualify if:

  • pregnancy
  • incapacity to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31839962DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 29, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2016

Last Updated

February 29, 2016

Record last verified: 2016-02