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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020104
Receipt No. R000023182
Scientific Title Mechanism of less frequent hemorrhage after cold polypectomy for colorectal polyps
Date of disclosure of the study information 2015/12/10
Last modified on 2020/08/10

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Basic information
Public title Mechanism of less frequent hemorrhage after cold polypectomy for colorectal polyps
Acronym Mechanism of CSP
Scientific Title Mechanism of less frequent hemorrhage after cold polypectomy for colorectal polyps
Scientific Title:Acronym Mechanism of CSP
Region
Japan

Condition
Condition Patients who receive colonoscopic resection
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare histological damage between hot and cold polypectomy
Basic objectives2 Others
Basic objectives -Others To clarify the mechanism of less frequent hemorrhage after cold polypectomy
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Depth of injury
Key secondary outcomes Number of injured vessels
Number of remaining intact vessels

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Endoscopically resect colorectal mucosa using two methods (hot or cold),
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients who are scheduled to receive colorectal resection for cancer
Key exclusion criteria Poor rsik, ASA 3 or greater
Hemorrhagic diathesis







9
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Kazutomo
Middle name
Last name Togashi
Organization Fukushima Medical University
Division name Aizu Medical Center
Zip code 969-3492
Address Aizuwakamatsu-city
TEL 0242-75-2100
Email togashik@fmu.ac.jp

Public contact
Name of contact person
1st name Jinko
Middle name
Last name Kobayashi
Organization Fukushima Medical University
Division name Aizu Medical Center
Zip code 969-3492
Address Aizuwakamatsu-city
TEL 0242-75-2100
Homepage URL
Email jinko-kb@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Fukushima Medical University
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukushima Medical University
Address 1 Hibarigaoka, Fukushima-city, Fukushima
Tel 024-547-1825
Email rs@fmu.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 福島県立医科大学会津医療センター附属病院(福島県)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 10 Day

Related information
URL releasing protocol DOI: 10.1097/DCR.0000000000001109
Publication of results Published

Result
URL related to results and publications DOI: 10.1097/DCR.0000000000001109
Number of participants that the trial has enrolled 15
Results
All cold resections were limited to the shallow submucosa, while 60% of hot resections advanced to the deep submucosa and 20% to the muscularis propria (p<0.001). There was no significant difference in the width of destruction. In hot resections, the number of remaining large vessels had a trend toward fewer (p=0.15) and the depth of remaining submucosa was less (p=0.007). In deep submucosa, the vessel diameter was larger (p<0.001) and the number of large vessels was greater (p=0.018).
Results date posted
2020 Year 08 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients scheduled to undergo colorectal resection
Participant flow
On the day before surgery, 2 mucosal resections (hot and cold) of normal mucosa were performed on each patient using the same snare without saline injection. The difference was only the application of electrocautery or not. Resection sites were placed close to the cancer to be included in the surgical specimen.
Adverse events
None
Outcome measures
The primary outcome measure was the depth of destruction. Secondary outcome measures included the width of destruction, depth of the remaining submucosa, and number of vessels remaining at the resection sites. The number and diameter of vessels in undamaged submucosa were also evaluated.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 06 Month 01 Day
Date of IRB
2014 Year 06 Month 01 Day
Anticipated trial start date
2015 Year 12 Month 10 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 02 Month 28 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 07 Day
Last modified on
2020 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023182

Research Plan
Registered date File name
2017/10/10 01 研究計画書(別紙様式1)CSPmechVer5.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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