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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040473
Receipt No. 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

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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
Email 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
Email simakit7@gmail.com

Sponsor
Institute Osaka police hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046198

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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