- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02007395
Prospective Study on Polypectomy Complications: SPoC.
December 5, 2013 updated by: Arnaldo Amato, Valduce Hospital
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
5170
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Population undergoing endoscopic polypectomy
Description
Inclusion Criteria:
- adult patients undergoing endoscopic polypectomy
Exclusion Criteria:
- pregnancy
- incapacity to give informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
colonoscopy population
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
complications of endoscopic polypectomy
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
December 5, 2013
First Submitted That Met QC Criteria
December 5, 2013
First Posted (Estimate)
December 10, 2013
Study Record Updates
Last Update Posted (Estimate)
December 10, 2013
Last Update Submitted That Met QC Criteria
December 5, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 5/2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Endoscopic Polypectomy
-
AstraZenecaJohnson & JohnsonCompletedSedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic PolypectomyJapan
-
Valduce HospitalUnknown
-
Valduce HospitalTerminated
-
VA Office of Research and DevelopmentCompletedPolypectomy | Post-polypectomy Bleeding | Elective ColonoscopyUnited States
-
AstraZenecaJohnson & Johnson K.K. Medical CompanyCompletedGastrointestinal Endoscopy | Gastrointestinal PolypectomyJapan
-
Ningbo No. 1 HospitalCompletedPolypectomy SnareChina
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University of Colorado, DenverRecruitingEndoscopic Suturing | Endoscopic Sleeve Gastroplasty | Endoscopic Tissue Apposition | Endoscopic Clipping | Bariatric Endoscopy | Transoral Outlet ReductionUnited States
-
Showa Inan General HospitalCompletedPostpolypectomy Bleeding | Diminutive Colorectal Polyp | Cold Snare Polypectomy | Polypectomy Snare | Complete Resection RateJapan
-
Qilu Hospital of Shandong UniversityQianfoshan Hospital; Shandong Second Provincial General HospitalNot yet recruitingEndoscopic Submucosal Dissection | Endoscopic Submucosal Dissection (ESD)
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Anchora MedicalRecruitingEndoscopic Mucosal Resection | Endoscopic Submucosal Dissection (ESD)Israel