UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017491 |
|---|---|
| Receipt number | R000020271 |
| Scientific Title | The efficacy of vacuum beanbag for maintaining lateral position during endoscopic submucosal dissection(ESD) |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2015/05/11 10:50:30 |
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Basic information
Public title
The efficacy of vacuum beanbag for maintaining lateral position during endoscopic submucosal dissection(ESD)
Acronym
The efficacy of vacuum beanbag for maintaining lateral position during ESD
Scientific Title
The efficacy of vacuum beanbag for maintaining lateral position during endoscopic submucosal dissection(ESD)
Scientific Title:Acronym
The efficacy of vacuum beanbag for maintaining lateral position during ESD
Region
| Japan |
Condition
Condition
gastric cancer/esophageal cancer/ESD
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of vacuum beanbag for maintaining lateral position during the ESD for esophageal cancer or gastric cancer under intravenous anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Frequency of repositioning during ESD
2.Presense of numbness,redness,pain after EDS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We use a vacuum beanbag for maintaining patient's position during ESD
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Case age is 20 years old or older
2.Provision of written informed consent
Key exclusion criteria
1.A person with BMI below 15
2.A person with BMI 35 and above
3.A person judged to be unsuitable for registration
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mariko Haga |
Organization
Hokkaido University Hospital
Division name
Nursing Department
Zip code
Address
North14 West5,Kita-ku,Sapporo,Hokkaido.Japan
TEL
011-716-1161
mh11240@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mariko Haga |
Organization
Hokkaido University Hospital
Division name
Nursing Department
Zip code
Address
North14 West5,Kita-ku,Sapporo,Hokkaido.Japan
TEL
011-716-1161
Homepage URL
mh11240@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Nursing Department
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 | 05 | Month | 11 | 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
The results indicate that a vacuum beanbag was effective for maintaining lateral position during ESD.
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
| 2011 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
20 participants (16 male, 4 female) were recruited for the study.
The maximun weight was 72.25 kg.
The minimum weight was 39.4 kg.
The mean BMI was 22.48.
No participant needed repositioning.
No pressure-related injury was observed.
Management information
Registered date
| 2015 | Year | 05 | Month | 11 | Day |
Last modified on
| 2015 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020271
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
