Difficult Colon Polypectomies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina
ClinicalTrials.gov Identifier:
NCT01504425
First received: January 3, 2012
Last updated: April 6, 2014
Last verified: April 2014
  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 Clinical Hospital Colentina:

Primary Outcome Measures:
  • complication rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 3, 2012
Last Updated: April 6, 2014
Health Authority: Romania: Ethics Committee

ClinicalTrials.gov processed this record on September 16, 2014