Assessing Endoloop-assisted Polypectomy in Patients With Antiplatelet Therapy

February 27, 2013 updated by: Dr Milutin Bulajic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pedunculated colorectal polyps
  • larger than 2cm in diameter
  • long-term antiplatelet therapy

Exclusion Criteria:

  • presence of intraepithelial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ligate and let go
Subjects are submitted to endoloop-assisted "ligate and let go" colorectal polypectomy.
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.
Active Comparator: Snare polypectomy
Subjects are submitted to endoloop-assisted snare colorectal polypectomy
Procedure: Endoloop-assisted snare colorectal polypectomy
The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps with consecutive snare polypectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-polypectomy bleeding
Time Frame: 24h-15 days
24h-15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Milutin Bulajic

Investigators

  • Principal Investigator: Milutin Bulajic, Dr, Hospital Danilo I Cetinje

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Estimate)

February 28, 2013

Last Update Submitted That Met QC Criteria

February 27, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • ENDL-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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