PolypectomySCALPNCT02694120
Study on Complications, EfficAcy and Costs of Large Polypectomy
An observational study of Polypectomy, run by Valduce Hospital.
Trial summary
Colonoscopy has been shown to reduce the incidence and mortality of colorectal cancer, through the recognition and removal of pre-cancerous lesions, which in most cases evolve with a sequence that goes through formation of high-grade dysplasia (HGD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polypectomy
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jul 2016
- How long will I take part?
- 6 Months
- 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: Population undergoing large endoscopic polypectomy
Who may be able to join
- adult patients undergoing large endoscopic polypectomy
Who cannot join
- pregnancy
- incapacity to give informed consent
About this study
Colonoscopy has been shown to reduce the incidence and mortality of colorectal cancer, through the recognition and removal of pre-cancerous lesions, which in most cases evolve with a sequence that goes through formation of high-grade dysplasia (HGD).
The probability of HGD increases with the increase of the lesion of the polyp itself. Lesions> 2 cm are present in 1% of colonoscopy screening. The resection of these lesions presents a greater technical difficulty and consequently a decrease in the efficiency. The rate of incomplete resection reported in the literature reaches 10% while that of recurrence / residual adenoma 16.4 / 31.7%.
The aim of the study SCALP is to evaluate the incidence of complications, efficacy and cost of endoscopic resection of colic lesions> 2cm in a setting of clinical practice in an unselected population
- Conditions
- 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 large polypectomy
incidence of polypectomy-related adverse events
Measured: 15 days
Secondary outcomes (2)
costs of large polypectomy
assessment of the average cost per procedure, including devices and staff costs
Measured: 15 days
efficacy of large polypectomy
assessment of residual adenoma at follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016 (estimated)
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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
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
- NCT02694120
- Sponsor's protocol ID
- 2016.2
- Acronym
- SCALP
- Status last verified
- Feb 2016
- First submitted
- 29 Jan 2016
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
Amato A, Radaelli F, Correale L, Di Giulio E, Buda A, Cennamo V, Fuccio L, Devani M, Tarantino O, Fiori G, De Nucci G, De Bellis M, Hassan C, Repici A; Bowell Group. Intra-procedural and delayed bleeding after resection of large colorectal lesions: The SCALP study. United European Gastroenterol J. 2019 Dec;7(10):1361-1372. doi: 10.1177/2050640619874176. Epub 2019 Sep 23.
PubMed 31839962
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Complications, EfficAcy and Costs of Large Polypectomy
- ClinicalTrials.gov ID
- NCT02694120
- Acronym / sponsor ID
- SCALP / 2016.2
- Conditions
- Polypectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (estimated)
- First posted
- 29 Feb 2016 (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 the incidence and mortality of colorectal cancer, through the recognition and removal of pre-cancerous lesions, which in most cases evolve with a sequence that goes through formation of high-grade dysplasia (HGD).
The probability of HGD increases with the increase of the lesion of the polyp itself. Lesions> 2 cm are present in 1% of colonoscopy screening. The resection of these lesions presents a greater technical difficulty and consequently a decrease in the efficiency. The rate of incomplete resection reported in the literature reaches 10% while that of recurrence / residual adenoma 16.4 / 31.7%.
The aim of the study SCALP is to evaluate the incidence of complications, efficacy and cost of endoscopic resection of colic lesions> 2cm in a setting of clinical practice in an unselected population
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colonoscopy population | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population undergoing large endoscopic polypectomy
Key inclusion criteria (1 listed)
- adult patients undergoing large 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 large polypectomy
Time frame: 15 days
incidence of polypectomy-related adverse events
2 secondary outcomes
costs of large polypectomy
Time frame: 15 days
efficacy of large polypectomy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Derived from this study: PubMed 31839962Amato A, Radaelli F, Correale L, Di Giulio E, Buda A, Cennamo V, Fuccio L, Devani M, Tarantino O, Fiori G, De Nucci G, De Bellis M, Hassan C, Repici A; Bowell Group. Intra-procedural and delayed bleeding after resection of large colorectal lesions: The SCALP study. United European Gastroenterol J. 2019 Dec;7(10):1361-1372. doi: 10.1177/2050640619874176. Epub 2019 Sep 23.
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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 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: status not confirmed, as of the sponsor's last update on 29 Feb 2016. 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?
Results are not available in the source record.
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 large polypectomy (time frame: 15 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 NCT02694120, 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 29 Feb 2016.