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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01800656
Other study ID # ENDL-001
Secondary ID
Status Completed
Phase N/A
First received February 26, 2013
Last updated February 27, 2013
Start date January 2004
Est. completion date December 2010

Study information

Verified date February 2013
Source Hospital Danilo I Cetinje
Contact n/a
Is FDA regulated No
Health authority Montenegro: Ministry of Health
Study type Interventional

Clinical Trial Summary

The aims of this study were to examine: 1) safety and feasibility of antiplatelet therapy interruption 7 days prior to polypectomy in patients with long-term antiplatelet therapy; 2) safety and feasibility of endoloop assisted snare polypectomy in patients with long-term antiplatelet therapy; 3) safety and feasibility of so called "ligate and let go" approach in patients with long-term antiplatelet therapy.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- pedunculated colorectal polyps

- larger than 2cm in diameter

- long-term antiplatelet therapy

Exclusion Criteria:

- presence of intraepithelial

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Endoloop-assisted "ligate and let go" colorectal polypectomy
The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps without consecutive snare polypectomy.
Endoloop-assisted snare colorectal polypectomy
The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps with consecutive snare polypectomy.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Dr Milutin Bulajic

Outcome

Type Measure Description Time frame Safety issue
Primary Post-polypectomy bleeding 24h-15 days No
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