- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01504425
Difficult Colon Polypectomies
April 6, 2014 updated by: dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina
An Observational Study of Difficult Colonic Polypectomies
The investigators aim to define the concept of difficult colonic polypectomy and investigate whether resection methods (hot/cold snare, Endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD)), adjuvant techniques (endoloop, prophylactic hemoclip placement, submucosal injection) and operator experience have an impact on polypectomy outcomes and complication rate.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
91
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bucharest, Romania
- Colentina Hospital
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with colonic polyps that are deemed difficult to resect
Description
Inclusion Criteria:
- colonic polyps that are deemed difficult to resect by the endoscopist
Exclusion Criteria:
- patient refusal to participate in the trial
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
complication rate
Time Frame: 30 days
|
the advent of hemorrhage or perforation during the 30 days following the endoscopic procedure
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Theodor Voiosu, Md, Clinical Hospital Colentina
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
December 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
January 3, 2012
First Submitted That Met QC Criteria
January 4, 2012
First Posted (Estimate)
January 5, 2012
Study Record Updates
Last Update Posted (Estimate)
April 8, 2014
Last Update Submitted That Met QC Criteria
April 6, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COL-GASTRO-1
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 Colon Polyps
-
Affiliated Hospital to Academy of Military Medical...UnknownSmall Colon Polyps | Linked Color Imagimg | Diminutive Colon PolypsChina
-
United States Naval Medical Center, PortsmouthWithdrawnColon Polyps | Colon Cancer ScreeningUnited States
-
IRCCS San RaffaeleUnknown
-
Biotax Labs LTDRecruiting
-
Seoul National University HospitalCompletedColon PolypKorea, Republic of
-
Portuguese Oncology Institute, CoimbraCompleted
-
Milton S. Hershey Medical CenterCompletedColon Cancer | Colon Adenoma | Colon PolypUnited States
-
White River Junction Veterans Affairs Medical CenterDartmouth College; Boston Scientific CorporationCompletedColon PolypsUnited States
-
London North West Healthcare NHS TrustCompletedColon PolypUnited Kingdom
-
Soonchunhyang University HospitalUnknownColon PolypKorea, Republic of