Colonic PolypsHOT/COLDNCT02484079
Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps
A study testing Polypectomy in people with Colonic Polyps and Colorectal Neoplasms, run by Sorlandet Hospital HF.
Trial summary
This study aims to investigate the comparative effectiveness between polyp removal with or without electrical current. The investigators want to include 600 polyps in the trial. It is known that polyps have the potential to develop to cancer if left in situ, but the investigators do not know the best way to remove… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colonic Polyps, Colorectal Neoplasms, Adenoma
- What is being tested?
- Polypectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2015to 31 Dec 2022
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient colonoscopy
- Signed, written informed consent
- At least one flat/sessile polyp sized 4-9 mm identified during colonoscopy
Who cannot join
- Implanted cardiac electro converter
- Severe comorbidity (NYHA 3-4)
- Known coagulopathy (INR > 1,8) or resent use of any of the new oral anti-coagulant medications
- Platelet count < 100
- Resent use of clopidogrel or other non-acetylsalicylic acid platelet inhibitor (Last dose < 5 days before the procedure)
- Previous biopsy or attempt of polypectomy of the polyp considered for inclusion in the trial
About this study
Official title: Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps. A Randomized Controlled Trial
This study aims to investigate the comparative effectiveness between polyp removal with or without electrical current. The investigators want to include 600 polyps in the trial.
It is known that polyps have the potential to develop to cancer if left in situ, but the investigators do not know the best way to remove them completely.
Read the detailed description
In this study the investigators want to compare to widely used methods for polyp removal; hot and cold snare polypectomy. There has not been performed any big studies on this subject earlier, but current knowledge indicates that hot polypectomy (i.e. with use of electrical current) is somewhat better with regard to complete resection of polyps compared to cold polypectomy (without electrical current).
In this project the patients will be randomized to either hot or cold polypectomy. The investigators will distribute videos of how the polypectomies should be performed, and a gastroenterologist in the project group will instruct the doctors examining the patients to make sure that everyone performs polypectomy according to current guidelines.
The study is designed as a non-inferiority trial.
- Conditions
- Colonic Polyps, Colorectal Neoplasms, Adenoma
- Being tested
- Polypectomy
- Medical subject headings
- Colonic Polyps, Colorectal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolypectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cold polypectomy | Active comparator | Patients in this arm will have their polyps removed by cold polypectomy, i.e. a metal sling that is closed around the basis of the polyp, and the polyp is cut off.
After removal there will be taken biopsies from the resection margins, and both the polyp and the biopsies will be examined by a histopathologist to see if the polyp is removed completely. Receives: Procedure: Polypectomy |
| Hot polypectomy | Active comparator | Patients in this arm will have their polyps removed by hot polypectomy, i.e. a metal sling taht is closed around the basis of the polyp, electrical currents is applied, and the polyp is cut off.
After removal there will be taken biopsies from the resection margins, and both the polyp and the biopsies will be examined by a histopathologist to see if the polyp is removed completely. Receives: Procedure: Polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection rate
We want to measure the rate of polyps that are resected completely, both with biopsies from the margin and the histopathologists evaluation of the resection margins of the polyp itself.
Measured: Hopefully within 4 weeks, when the histopathologist has examined the biopsies
Secondary outcomes (5)
Complications
We want to register early (during the procedure) and late (within 4 weeks after the procedure) complications.
Complications we will record is bleeding/blood in the stool, perforation and patient contact with health care provider
Measured: 4 weeks
Factors explaining the primary outcome
Patient characteristics
Measured: During the hospital stay and up to 4 weeks.
Factors explaining the primary outcome
Doctor characteristics
Measured: During the hospital stay and up to 4 weeks
Factors explaining the primary outcome
Procedure characteristics
Measured: During the hospital stay and up to 4 weeks
Factors explaining the primary outcome
Histology of polyps, correlation between resection margins and biopsies, correlation between optical and histopathological diagnosis
Measured: During the hospital stay and up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start18 May 2015
- Primary completion20 May 2020
- Study completion31 Dec 2022
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 Colonic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484079
- Sponsor's protocol ID
- SorlandetHF
- Acronym
- HOT/COLD
- Status last verified
- Dec 2021
- First submitted
- 24 Apr 2015
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Pedersen IB, Rawa-Golebiewska A, Calderwood AH, Brix LD, Grode LB, Botteri E, Bugajski M, Kaminski MF, Januszewicz W, Odegaard H, Kleist B, Kalager M, Loberg M, Bretthauer M, Hoff G, Medhus A, Holme O. Complete polyp resection with cold snare versus hot snare polypectomy for polyps of 4-9 mm: a randomized controlled trial. Endoscopy. 2022 Oct;54(10):961-969. doi: 10.1055/a-1734-7952. Epub 2022 Jan 10.
PubMed 35008112
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Hot Versus Cold Snare Polypectomy of Small Colorectal Polyps. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02484079
- Acronym / sponsor ID
- HOT/COLD / SorlandetHF
- Conditions
- Colonic Polyps, Colorectal Neoplasms, Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- 18 May 2015 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 Jun 2015 (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.
This study aims to investigate the comparative effectiveness between polyp removal with or without electrical current. The investigators want to include 600 polyps in the trial.
It is known that polyps have the potential to develop to cancer if left in situ, but the investigators do not know the best way to remove them completely.
Detailed description
In this study the investigators want to compare to widely used methods for polyp removal; hot and cold snare polypectomy. There has not been performed any big studies on this subject earlier, but current knowledge indicates that hot polypectomy (i.e. with use of electrical current) is somewhat better with regard to complete resection of polyps compared to cold polypectomy (without electrical current).
In this project the patients will be randomized to either hot or cold polypectomy. The investigators will distribute videos of how the polypectomies should be performed, and a gastroenterologist in the project group will instruct the doctors examining the patients to make sure that everyone performs polypectomy according to current guidelines.
The study is designed as a non-inferiority trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold polypectomy | Active comparator | Procedure: PolypectomyPatients in this arm will have their polyps removed by cold polypectomy, i.e. a metal sling that is closed around the basis of the polyp, and the polyp is cut off. After removal there will be taken biopsies from the resection margins, and both the polyp and the biopsies will be examined by a histopathologist to see if the polyp is removed completely. |
| Hot polypectomy | Active comparator | Procedure: PolypectomyPatients in this arm will have their polyps removed by hot polypectomy, i.e. a metal sling taht is closed around the basis of the polyp, electrical currents is applied, and the polyp is cut off. After removal there will be taken biopsies from the resection margins, and both the polyp and the biopsies will be examined by a histopathologist to see if the polyp is removed completely. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatient colonoscopy
- Signed, written informed consent
- At least one flat/sessile polyp sized 4-9 mm identified during colonoscopy
Key exclusion criteria (6 listed)
- Implanted cardiac electro converter
- Severe comorbidity (NYHA 3-4)
- Known coagulopathy (INR > 1,8) or resent use of any of the new oral anti-coagulant medications
- Platelet count < 100
- Resent use of clopidogrel or other non-acetylsalicylic acid platelet inhibitor (Last dose < 5 days before the procedure)
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 |
|---|---|---|
| Polypectomy | Procedure or surgery | Cold polypectomy, Hot polypectomy |
Primary outcome
Complete resection rate
Time frame: Hopefully within 4 weeks, when the histopathologist has examined the biopsies
We want to measure the rate of polyps that are resected completely, both with biopsies from the margin and the histopathologists evaluation of the resection margins of the polyp itself.
5 secondary outcomes
Complications
Time frame: 4 weeks
Factors explaining the primary outcome
Time frame: During the hospital stay and up to 4 weeks.
Factors explaining the primary outcome
Time frame: During the hospital stay and up to 4 weeks
Factors explaining the primary outcome
Time frame: During the hospital stay and up to 4 weeks
Factors explaining the primary outcome
Time frame: During the hospital stay and up to 4 weeks
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 23 Feb 2023.
- Derived from this study: PubMed 35008112Pedersen IB, Rawa-Golebiewska A, Calderwood AH, Brix LD, Grode LB, Botteri E, Bugajski M, Kaminski MF, Januszewicz W, Odegaard H, Kleist B, Kalager M, Loberg M, Bretthauer M, Hoff G, Medhus A, Holme O. Complete polyp resection with cold snare versus hot snare polypectomy for polyps of 4-9 mm: a randomized controlled trial. Endoscopy. 2022 Oct;54(10):961-969. doi: 10.1055/a-1734-7952. Epub 2022 Jan 10.
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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?
A study testing Polypectomy in people with Colonic Polyps and Colorectal Neoplasms, run by Sorlandet Hospital HF.
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 6 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 23 Feb 2023. 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?
Complete resection rate (time frame: Hopefully within 4 weeks, when the histopathologist has examined the biopsies). 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 NCT02484079, 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 23 Feb 2023.