Risk of Post-polypectomy Bleeding With Prophylactic Hemoclipping

Polypectomy Clinical Trial

Official title:

Risk of Post-Polypectomy Bleeding With Prophylactic Hemoclipping

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647581
• Other study ID #: CLNB-005-13F
• Secondary ID: DVAMC-11-026
• Status: Completed
• Phase: N/A
• Start date: September 1, 2011
• Est. completion date: November 1, 2018

Study information

• Verified date: September 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized trial aimed at determining whether or not hemoclips are effective in preventing post-polypectomy bleeds on polyps that are 10mm in size or greater.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11182
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients presenting for elective colonoscopy

Exclusion Criteria:

• Patients in which polypectomy can not be performed safely

Related Conditions & MeSH terms

• Elective Colonoscopy
• Hemorrhage
• Polypectomy
• Post-polypectomy Bleeding

Intervention

Device:
• Hemoclip Placement
Placement of hemoclip at polypectomy site for polyps at least 1cm in size
• NO hemoclip placement
No hemoclip placement (placebo / sham)

Locations

Country	Name	City	State
United States	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas
United States	South Texas Health Care System, San Antonio, TX	San Antonio	Texas
United States	Central Texas Veterans Health Care System, Temple, TX	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Delayed Post Polypectomy Bleeding	rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery	30 days