UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018288 |
|---|---|
| Receipt number | R000021158 |
| Scientific Title | A prospective exploratory study on the evaluation of post-polypectomy sites after conventional and cold polypectomy for rectal polyps |
| Date of disclosure of the study information | 2015/07/13 |
| Last modified on | 2018/02/03 14:13:29 |
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Basic information
Public title
A prospective exploratory study on the evaluation of post-polypectomy sites after conventional and cold polypectomy for rectal polyps
Acronym
the endoscopic evaluation after conventional and cold polypectomy
Scientific Title
A prospective exploratory study on the evaluation of post-polypectomy sites after conventional and cold polypectomy for rectal polyps
Scientific Title:Acronym
the endoscopic evaluation after conventional and cold polypectomy
Region
| Japan |
Condition
Condition
rectal and rectosigmoid polyps
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the post-polypectomy site after conventional and cold polypectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
The endoscopic evaluation of post-polypectomy site (size of ulcer, presence of blood, presence of residual tumor)
Key secondary outcomes
The resection depth
The incidence of immediate bleeding
The incidence of delayed bleeding
The incidence of delayed perforation
The pathological evaluation of complete resection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
conventional snare polypectomy
Interventions/Control_2
cold snare polypectomy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 20 years old and older
2) Patients with rectal or rectosigmoid polyps less than 10 mm in diameter
3) Written informed consent
Key exclusion criteria
1) Polyps suspected of being cancers
2) Patients with diseases that cause the bleeding tendency
3) Patients who have serious complications
4) Pregnant
5) Others
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sho Suzuki |
Organization
Yuri-Kumiai General Hospital
Division name
Department of Gastroenterology
Zip code
Address
38, Kawaguchiazayago, Yurihonjoshi, Akita, Japan
TEL
0184-27-1200
s.sho.salubriter.mail@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sho Suzuki |
Organization
Yuri-Kumiai General Hospital
Division name
Department of Gastroenterology
Zip code
Address
38, Kawaguchiazayago, Yurihonjoshi, Akita, Japan
TEL
0184-27-1200
Homepage URL
s.sho.salubriter.mail@gmail.com
Sponsor or person
Institute
Yuri-Kumiai General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 13 | Day |
Last modified on
| 2018 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021158
