Colon PolypsNCT01504425
Difficult Colon Polypectomies
An observational study of Colon Polyps, run by Clinical Hospital Colentina at 1 site in Romania.
Trial summary
The investigators aim to define the concept of difficult colonic polypectomy and investigate whether resection methods (hot/cold snare, Endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD)), adjuvant techniques (endoloop, prophylactic hemoclip placement, submucosal injection) and operator… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Polyps
- How many people
- 91 participants
- Where
- 1 siteRomania
- Study dates
- Dec 2011to Mar 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with colonic polyps that are deemed difficult to resect
Who may be able to join
- colonic polyps that are deemed difficult to resect by the endoscopist
Who cannot join
- patient refusal to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of Difficult Colonic Polypectomies
The investigators aim to define the concept of difficult colonic polypectomy and investigate whether resection methods (hot/cold snare, Endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD)), adjuvant techniques (endoloop, prophylactic hemoclip placement, submucosal injection) and operator experience have an impact on polypectomy outcomes and complication rate.
- Conditions
- Colon Polyps
- Medical subject headings
- Colonic Polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
complication rate
the advent of hemorrhage or perforation during the 30 days following the endoscopic procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon PolypsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Colentina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina
- Investigators
- Theodor Voiosu, MD, Principal investigator, Clinical Hospital Colentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504425
- Sponsor's protocol ID
- COL-GASTRO-1
- Status last verified
- Apr 2014
- First submitted
- 3 Jan 2012
- Last updated
- 8 Apr 2014
- Results posted
- No
Publications
Voiosu T, Ratiu I, Hervoso CM, Furnari M, Voiosu A, Goldis A, Mateescu B, Tacconi M, Dulbecco P, Haidar A, Voiosu MR, Sporea I. Polyp and endoscopist-related factors influencing complication rates in difficult colonic polypectomies: results of a multicenter observational study. Rom J Intern Med. 2013 Jul-Dec;51(3-4):172-8.
PubMed 24620630
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Difficult Colonic Polypectomies
- ClinicalTrials.gov ID
- NCT01504425
- Acronym / sponsor ID
- COL-GASTRO-1
- Conditions
- Colon Polyps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Clinical Hospital ColentinaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Jan 2012 (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 investigators aim to define the concept of difficult colonic polypectomy and investigate whether resection methods (hot/cold snare, Endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD)), adjuvant techniques (endoloop, prophylactic hemoclip placement, submucosal injection) and operator experience have an impact on polypectomy outcomes and complication rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with colonic polyps that are deemed difficult to resect
Key inclusion criteria (1 listed)
- colonic polyps that are deemed difficult to resect by the endoscopist
Key exclusion criteria (1 listed)
- patient refusal to participate in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
complication rate
Time frame: 30 days
the advent of hemorrhage or perforation during the 30 days following the endoscopic procedure
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 8 Apr 2014.
- Results publication: PubMed 24620630Voiosu T, Ratiu I, Hervoso CM, Furnari M, Voiosu A, Goldis A, Mateescu B, Tacconi M, Dulbecco P, Haidar A, Voiosu MR, Sporea I. Polyp and endoscopist-related factors influencing complication rates in difficult colonic polypectomies: results of a multicenter observational study. Rom J Intern Med. 2013 Jul-Dec;51(3-4):172-8.
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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.
Theodor Voiosu, MD principal investigator
Clinical Hospital Colentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Polyps, run by Clinical Hospital Colentina at 1 site in Romania.
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 1 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 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
complication rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01504425, which also lists 1 linked publication.
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 8 Apr 2014; AzTrials last refreshed its copy on 27 Oct 2026.