UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040473 |
|---|---|
| Receipt number | R000046198 |
| Scientific Title | Water-slider method reduced colonic polyp fragmentation compared with conventional suction retrieval: A prospective randomized controlled study. |
| Date of disclosure of the study information | 2020/05/21 |
| Last modified on | 2020/05/22 00:38:25 |
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Basic information
Public title
Water-slider method reduced colonic polyp fragmentation compared with conventional suction retrieval.
Acronym
The Water-slider method avoids colonic polyp fragmentation.
Scientific Title
Water-slider method reduced colonic polyp fragmentation compared with conventional suction retrieval: A prospective randomized controlled study.
Scientific Title:Acronym
The Water-slider method avoids colonic polyp fragmentation.
Region
| Japan |
Condition
Condition
colonic polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate whether water-slider method (WSM) decreases polyp fragmentation compared with a conventional polyp removal method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Polyp fragmentation rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Use water-slider method to retrieve resected polyps.
1. Resect the polyp using a snare.
2. Minimally draw the resected specimen toward the suction channel to avoid polyp loss. It is important not to fully push the suction button.
3. Using a water-jet channel, add enough water to a nearby site in the colon.
4. Push the suction button fully to suck the polyp in with the water.
Interventions/Control_2
Retrieve the resected specimen without adding water and without designating how to use the suction button (i.e., conventional suction retrieval).
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
Patients that underwent endoscopic resection of colonic polyps from November through December 2019 at our institute were included.
Key exclusion criteria
Patients who rejected to participate was excluded.
Polyps that were not resected en bloc were excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Shimayoshi |
Organization
Osaka police hospital
Division name
Division of Internal Medicine
Zip code
543-0035
Address
10-31, Kitayama-cho, Tennoji-ku, Osaka-shi, Osaka-Fu
TEL
0667716051
simakit7@gmail.com
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Shimayoshi |
Organization
Osaka police hospital
Division name
Division of Internal Medicine
Zip code
5430035
Address
10-31, Kitayama-cho, Tennoji-ku, Osaka-shi, Osaka-Fu
TEL
0667716051
Homepage URL
simakit7@gmail.com
Sponsor or person
Institute
Osaka police hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka police hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka police hospital
Address
10-31, Kitayama-cho, Tennoji-ku, Osaka-shi, Osaka-Fu
Tel
0667716051
simakit7@gmail.com
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
大阪警察病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
90
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
| 2019 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 21 | Day |
Last modified on
| 2020 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046198
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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