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Difficult Colon Polypectomies

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ClinicalTrials.gov Identifier: NCT01504425
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Primary Completion Date : March 2013
Study Completion Date : March 2014
Groups and Cohorts


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations

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
Romania
Colentina Hospital
Bucharest, Romania
Sponsors and Collaborators
Clinical Hospital Colentina
Investigators
Principal Investigator: Theodor Voiosu, MD Clinical Hospital Colentina