Colorectal CancerCOLDNCT00763425
Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy
A study testing cold polypectomy and conventional polypectomy in people with Colorectal Cancer, run by Showa Inan General Hospital at 1 site in Japan.
Trial summary
The aim of this study is to compare cold snare polypectomy and conventional polypectomy for the removal and retrieval of small colorectal polyps. Cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than conventional polypectomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- cold polypectomy and conventional polypectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2008to Sep 2009
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women between 20 and 100 years of age
Who cannot join
- Pregnant, American Society of Anesthesiologists class III and IV
- Overweight (body weight > 100 kg)
- Allergic to the drugs used or its components (soybeans or eggs)
- Poor bowel preparation or post-colorectal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare cold snare polypectomy and conventional polypectomy for the removal and retrieval of small colorectal polyps.
Cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than conventional polypectomy.
- Conditions
- Colorectal Cancer
- Being tested
- cold polypectomy, conventional polypectomy
- Keywords
- polypectomy, colonic polyp, colorectal polyp, colorectal cancer prevention
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold polypectomyProcedure or surgery
Also called cold snare polypectomy
The removal of small colorectal polyps up to 8 mm is performed using cold snare polypectomy.
conventional polypectomyProcedure or surgery
Also called polypectomy
The removal of small colorectal polyps up to 8 mm is performed using conventional polypectomy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: cold polypectomy |
| 2 | Active comparator | Not described Receives: Procedure: conventional polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete removal rate of colorectal polyps
Measured: two weeks after each polypectomy
Secondary outcomes (1)
Complication rate
Measured: two weeks after each polypectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Showa Inan General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akira Horiuchi, Showa Inan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763425
- Sponsor's protocol ID
- 200888
- Acronym
- COLD
- Status last verified
- Nov 2015
- First submitted
- 29 Sep 2008
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy
- ClinicalTrials.gov ID
- NCT00763425
- Acronym / sponsor ID
- COLD / 200888
- Conditions
- Colorectal Cancer
- Keywords
- polypectomy, colonic polyp, colorectal polyp, colorectal cancer prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Showa Inan General HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 1 Oct 2008 (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 aim of this study is to compare cold snare polypectomy and conventional polypectomy for the removal and retrieval of small colorectal polyps.
Cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than conventional polypectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: cold polypectomy |
| 2 | Active comparator | Procedure: conventional polypectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men or women between 20 and 100 years of age
Key exclusion criteria (4 listed)
- Pregnant, American Society of Anesthesiologists class III and IV
- Overweight (body weight > 100 kg)
- Allergic to the drugs used or its components (soybeans or eggs)
- Poor bowel preparation or post-colorectal surgery.
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 |
|---|---|---|
| cold polypectomyAlso: cold snare polypectomyThe removal of small colorectal polyps up to 8 mm is performed using cold snare polypectomy. | Procedure or surgery | 1 |
| conventional polypectomyAlso: polypectomyThe removal of small colorectal polyps up to 8 mm is performed using conventional polypectomy. | Procedure or surgery | 2 |
Primary outcome
Complete removal rate of colorectal polyps
Time frame: two weeks after each polypectomy
1 secondary outcome
Complication rate
Time frame: two weeks after each polypectomy
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 18 Nov 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold polypectomy and conventional polypectomy in people with Colorectal Cancer, run by Showa Inan General Hospital at 1 site in Japan.
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 4 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 18 Nov 2015. 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 Japan. 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?
Complete removal rate of colorectal polyps (time frame: two weeks after each polypectomy). 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 18 Nov 2015.