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Difficult Colon Polypectomies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01504425
First Posted: January 5, 2012
Last Update Posted: April 8, 2014
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.
Information provided by (Responsible Party):
dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina
  Purpose
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
Colon Polyps

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Difficult Colonic Polypectomies

Further study details as provided by dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina:

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


Enrollment: 91
Study Start Date: December 2011
Study Completion Date: March 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

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
  More Information

Publications:
Responsible Party: dr. Theodor Alexandru Voiosu, MD, Clinical Hospital Colentina
ClinicalTrials.gov Identifier: NCT01504425     History of Changes
Other Study ID Numbers: COL-GASTRO-1
First Submitted: January 3, 2012
First Posted: January 5, 2012
Last Update Posted: April 8, 2014
Last Verified: April 2014