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Difficult Colon Polypectomies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01504425
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina

Brief Summary:
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.

Condition or disease
Colon Polyps

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Study Type : Observational
Actual Enrollment : 91 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Difficult Colonic Polypectomies
Study Start Date : December 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2014



Primary Outcome Measures :
  1. complication rate [ Time Frame: 30 days ]
    the advent of hemorrhage or perforation during the 30 days following the endoscopic procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with colonic polyps that are deemed difficult to resect
Criteria

Inclusion Criteria:

  • colonic polyps that are deemed difficult to resect by the endoscopist

Exclusion Criteria:

  • patient refusal to participate in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504425


Locations
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Romania
Colentina Hospital
Bucharest, Romania
Sponsors and Collaborators
Clinical Hospital Colentina
Investigators
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Principal Investigator: Theodor Voiosu, MD Clinical Hospital Colentina
Publications of Results:
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Responsible Party: dr. Theodor Alexandru Voiosu, MD, Clinical Hospital Colentina
ClinicalTrials.gov Identifier: NCT01504425    
Other Study ID Numbers: COL-GASTRO-1
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical