Assessing Endoloop-assisted Polypectomy in Patients With Antiplatelet Therapy

Colorectal Polyp Clinical Trial

Official title:

Endoloop-assisted Colorectal Polypectomy or "Ligate and Let go" in Patients With Long-term Antiplatelet Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800656
• Other study ID #: ENDL-001
• 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

• Colorectal Polyp

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