Viewing Study NCT01565993


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Study NCT ID: NCT01565993
Status: TERMINATED
Last Update Posted: 2012-05-25
First Post: 2012-03-27
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: The Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps
Sponsor: Hospital Severo Ochoa
Organization:

Study Overview

Official Title: Is the Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps Useful? A Prospective and Randomized Study
Status: TERMINATED
Status Verified Date: 2012-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: The unexpected increase in morbidity of the hemoclip group
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aim of our study is to analyze the advantages of the prophylactic use of hemoclips before polypectomy in our usual clinical practice, through a prospective randomized study that determines their effectiveness compared to conventional polypectomy, assessing the decrease in immediate and delayed post-polypectomy bleeding
Detailed Description: The methods for preventing post-polypectomy bleeding (PPB) are not standardised and there are groups that use hemoclips for this purpose.

The aim of our study is to analyze whether the use of hemoclips reduces PPB complications. It is a prospective, randomised study of patients with pedunculated polyps larger than 10mm. The patients were included in two groups (hemoclip before polypectomy -HC- and standard polypectomy -SP-)

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: