Endoscopic PolypectomyNCT02007395
Prospective Study on Polypectomy Complications: SPoC.
An observational study of Endoscopic Polypectomy, run by Valduce Hospital.
Trial summary
Colonoscopy has been shown to reduce both the colo-rectal cancer incidence and mortality, due to its capability to detect and remove precancerous lesions. However, polypectomy is associated with complications, such as bleeding and perforation, with an estimated overall incidence of about 10%, with polyp size and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endoscopic Polypectomy
- How many people
- 5,170 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Dec 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population undergoing endoscopic polypectomy
Who may be able to join
- adult patients undergoing endoscopic polypectomy
Who cannot join
- pregnancy
- incapacity to give informed consent
About this study
Colonoscopy has been shown to reduce both the colo-rectal cancer incidence and mortality, due to its capability to detect and remove precancerous lesions. However, polypectomy is associated with complications, such as bleeding and perforation, with an estimated overall incidence of about 10%, with polyp size and right-sided location considered as major risk factors. Aim of present study was to prospectively evaluate the early and delayed (30-days follow-up) complications of polypectomy in a multicenter regional Italian real practice setting
- Conditions
- Endoscopic Polypectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| colonoscopy population | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications of endoscopic polypectomy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic PolypectomyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaldo Amato, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007395
- Sponsor's protocol ID
- 5/2013
- Status last verified
- Dec 2013
- First submitted
- 5 Dec 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Polypectomy Complications: SPoC.
- ClinicalTrials.gov ID
- NCT02007395
- Acronym / sponsor ID
- 5/2013
- Conditions
- Endoscopic Polypectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,170 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Dec 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.
Colonoscopy has been shown to reduce both the colo-rectal cancer incidence and mortality, due to its capability to detect and remove precancerous lesions. However, polypectomy is associated with complications, such as bleeding and perforation, with an estimated overall incidence of about 10%, with polyp size and right-sided location considered as major risk factors. Aim of present study was to prospectively evaluate the early and delayed (30-days follow-up) complications of polypectomy in a multicenter regional Italian real practice setting
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colonoscopy population | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population undergoing endoscopic polypectomy
Key inclusion criteria (1 listed)
- adult patients undergoing endoscopic polypectomy
Key exclusion criteria (2 listed)
- pregnancy
- incapacity to give informed consent
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
complications of endoscopic polypectomy
Time frame: 3 months
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 10 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Polypectomy, run by Valduce Hospital.
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 2 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 10 Dec 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?
complications of endoscopic polypectomy (time frame: 3 months). 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 10 Dec 2013.