Colonic Polyps/Colonoscopy/Colorectal NeoplasmsNCT04451512
Comparison of Cold and Hot Snare Resection for Colorectal Polyps Sized 10-19mm.
An observational study of Colonic Polyps/Colonoscopy/Colorectal Neoplasms, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or hot snare were included in the study, signed by endoscopic treatment written informed consent for surgery, patients with detailed tracking and record the basic information and information related to the operation, postoperative… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonic Polyps/Colonoscopy/Colorectal Neoplasms
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Jan 2021
- 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: Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or hot snare were included in the study.
Who may be able to join
- colorectal polyps sized 10≤ diameter ≤19 mm;
- Boston bowel prepare score: 5-9;
- The patients all signed the informed consent of endoscopic treatment.
Who cannot join
- Complicated with inflammatory bowel disease, P-J syndrome or familial polyposis;
- Complicated with malignant tumors;
- polyp size is uncertain;
- Currently taking aspirin, warfarin or other anticoagulants.
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of xi'an jiaotong university
Xi'an, Shaanxi, 710004
About this study
Official title: A Prospective Observational Study of Cold and Hot Snare Resection for Colorectal Polyps Sized 10-19mm.
Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or hot snare were included in the study, signed by endoscopic treatment written informed consent for surgery, patients with detailed tracking and record the basic information and information related to the operation, postoperative lack of region and edge endoscopic observation carefully no residue, additional excision may be took if necessary，after resection specimen inspection, and in 6 months review colonoscopy, assess whether there is residual or recurrence of polyps.Main outcome: technical success rate (no other auxiliary resection), complete resection rate, secondary outcome: intraoperative and postoperative complications, polypectomy time and related costs, influential factors of incomplete resection.Research significance: The effectiveness, safety and cost-effectiveness of cold and hot snare resection of 10-19mm colorectal polyps were compared, and the influencing factors of incomplete polyps resection were analyzed, so as to provide evidence for the decision on the best method of medium-size polyps resection.
- Medical subject headings
- Colonic Polyps
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 |
|---|---|---|
| CSP | Not described | |
| HSP | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
(without other auxiliary resection)
Measured: 2020.07.31
Complete resection rate
Measured: 2021.01.31
Secondary outcomes (3)
Intraoperative and postoperative complications
Measured: 2021.01.31
Polypectomy time
Measured: 2021.01.31
related costs of treatment
Measured: 2021.01.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Jan 2020
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic Polyps/Colonoscopy/Colorectal NeoplasmsStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451512
- Sponsor's protocol ID
- 20200615
- Status last verified
- Jun 2020
- First submitted
- 17 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Cold and Hot Snare Resection for Colorectal Polyps Sized 10-19mm.
- ClinicalTrials.gov ID
- NCT04451512
- Acronym / sponsor ID
- 20200615
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 30 Jun 2020 (actual)
- 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.
Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or hot snare were included in the study, signed by endoscopic treatment written informed consent for surgery, patients with detailed tracking and record the basic information and information related to the operation, postoperative lack of region and edge endoscopic observation carefully no residue, additional excision may be took if necessary，after resection specimen inspection, and in 6 months review colonoscopy, assess whether there is residual or recurrence of polyps.Main outcome: technical success rate (no other auxiliary resection), complete resection rate, secondary outcome: intraoperative and postoperative complications, polypectomy time and related costs, influential factors of incomplete resection.Research significance: The effectiveness, safety and cost-effectiveness of cold and hot snare resection of 10-19mm colorectal polyps were compared, and the influencing factors of incomplete polyps resection were analyzed, so as to provide evidence for the decision on the best method of medium-size polyps resection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSP | – | – |
| HSP | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or hot snare were included in the study.
Key inclusion criteria (3 listed)
- colorectal polyps sized 10≤ diameter ≤19 mm;
- Boston bowel prepare score: 5-9;
- The patients all signed the informed consent of endoscopic treatment.
Key exclusion criteria (4 listed)
- Complicated with inflammatory bowel disease, P-J syndrome or familial polyposis;
- Complicated with malignant tumors;
- polyp size is uncertain;
- Currently taking aspirin, warfarin or other anticoagulants.
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
Technical success rate
Time frame: 2020.07.31
(without other auxiliary resection)
Complete resection rate
Time frame: 2021.01.31
3 secondary outcomes
Intraoperative and postoperative complications
Time frame: 2021.01.31
Polypectomy time
Time frame: 2021.01.31
related costs of treatment
Time frame: 2021.01.31
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Colonic Polyps/Colonoscopy/Colorectal Neoplasms, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 30 Jun 2020. 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 China. 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?
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?
Technical success rate (time frame: 2020.07.31). The study lists 2 primary outcomes in all. 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 30 Jun 2020.