Prospective Study on Polypectomy Complications: SPoC. | NCT02007395

Studies
Prospective Study on Polypectomy Complications: SPoC.

NCT02007395

Sponsor

Valduce Hospital

Status

Completed

Last Update Posted

Dec 10, 2013Estimated

Enrollment

5,170Actual

Phase

Not provided

Conditions

Endoscopic Polypectomy

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Sep 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Dec 5, 2013

First Submission Date that Met QC Criteria

Dec 5, 2013

First Posted Date

Dec 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2013

Last Update Posted Date

Dec 10, 2013Estimated

Description Module

Brief Summary

Colonoscopy has been shown to reduce both the colo-rectal cancer incidence and mortality, due to its capability to detect and remove precancerous lesions. However, polypectomy is associated with complications, such as bleeding and perforation, with an estimated overall incidence of about 10%, with polyp size and right-sided location considered as major risk factors. Aim of present study was to prospectively evaluate the early and delayed (30-days follow-up) complications of polypectomy in a multicenter regional Italian real practice setting

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,170Actual

Label	Type	Description	Intervention Names
colonoscopy population

Measure	Description	Time Frame
complications of endoscopic polypectomy		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients undergoing endoscopic polypectomy

Exclusion Criteria:

pregnancy
incapacity to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Population undergoing endoscopic polypectomy

Sampling Method

Non-Probability Sample