Colorectal PolypNCT01800656
Assessing Endoloop-assisted Polypectomy in Patients With Antiplatelet Therapy
A study testing Endoloop-assisted "ligate and let go" colorectal polypectomy and Endoloop-assisted snare colorectal polypectomy in people with Colorectal Polyp, run by Dr Milutin Bulajic.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Polyp
- What is being tested?
- Endoloop-assisted "ligate and let go" colorectal polypectomy and Endoloop-assisted snare colorectal polypectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pedunculated colorectal polyps
- larger than 2cm in diameter
- long-term antiplatelet therapy
Who cannot join
- presence of intraepithelial
About this study
Official title: 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.
- Conditions
- Colorectal Polyp
- Being tested
- Endoloop-assisted "ligate and let go" colorectal polypectomy, Endoloop-assisted snare colorectal polypectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoloop-assisted "ligate and let go" colorectal polypectomyProcedure or surgery
The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps without consecutive snare polypectomy.
Endoloop-assisted snare colorectal polypectomyProcedure or surgery
The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps with consecutive snare polypectomy.
| Study group | Role | What they receive |
|---|---|---|
| Ligate and let go | Experimental | Subjects are submitted to endoloop-assisted "ligate and let go" colorectal polypectomy. Receives: Procedure: Endoloop-assisted "ligate and let go" colorectal polypectomy |
| Snare polypectomy | Active comparator | Subjects are submitted to endoloop-assisted snare colorectal polypectomy Receives: Procedure: Endoloop-assisted snare colorectal polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-polypectomy bleeding
Measured: 24h-15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startJan 2004
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Milutin Bulajic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Milutin Bulajic, Hospital Danilo I Cetinje
- Investigators
- Milutin Bulajic, Dr, Principal investigator, Hospital Danilo I Cetinje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800656
- Sponsor's protocol ID
- ENDL-001
- Status last verified
- Feb 2013
- First submitted
- 26 Feb 2013
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoloop-assisted Colorectal Polypectomy or "Ligate and Let go" in Patients With Long-term Antiplatelet Therapy
- ClinicalTrials.gov ID
- NCT01800656
- Acronym / sponsor ID
- ENDL-001
- Conditions
- Colorectal Polyp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dr Milutin BulajicUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligate and let go | Experimental | Procedure: Endoloop-assisted "ligate and let go" colorectal polypectomySubjects are submitted to endoloop-assisted "ligate and let go" colorectal polypectomy. |
| Snare polypectomy | Active comparator | Procedure: Endoloop-assisted snare colorectal polypectomySubjects are submitted to endoloop-assisted snare colorectal polypectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pedunculated colorectal polyps
- larger than 2cm in diameter
- long-term antiplatelet therapy
Key exclusion criteria (1 listed)
- presence of intraepithelial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoloop-assisted "ligate and let go" colorectal polypectomyThe technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps without consecutive snare polypectomy. | Procedure or surgery | Ligate and let go |
| Endoloop-assisted snare colorectal polypectomyThe technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps with consecutive snare polypectomy. | Procedure or surgery | Snare polypectomy |
Primary outcome
Post-polypectomy bleeding
Time frame: 24h-15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milutin Bulajic, Dr principal investigator
Hospital Danilo I Cetinje
Questions about this trial
What is this clinical trial studying?
A study testing Endoloop-assisted "ligate and let go" colorectal polypectomy and Endoloop-assisted snare colorectal polypectomy in people with Colorectal Polyp, run by Dr Milutin Bulajic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-polypectomy bleeding (time frame: 24h-15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2013.