UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013926 |
|---|---|
| Receipt number | R000016240 |
| Scientific Title | a study of tissue adhesive (DERMABOND TM) in transumbilical approach for laparo-endoscopic surgery |
| Date of disclosure of the study information | 2014/05/12 |
| Last modified on | 2020/08/20 18:20:48 |
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Basic information
Public title
a study of tissue adhesive (DERMABOND TM) in transumbilical approach for laparo-endoscopic surgery
Acronym
a study of tissue adhesive (DERMABOND TM) in transumbilical approach for laparo-endoscopic surgery
Scientific Title
a study of tissue adhesive (DERMABOND TM) in transumbilical approach for laparo-endoscopic surgery
Scientific Title:Acronym
a study of tissue adhesive (DERMABOND TM) in transumbilical approach for laparo-endoscopic surgery
Region
| Japan |
Condition
Condition
adrenal tumor
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to declear whether there is a significant difference by using DERMABOND TM in transumbilical laparo-endoscopic surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
use of DERMABOND TM
Interventions/Control_2
control
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patient who can understand this study and decided to join this study
2. patient who will undergo transumbilical laparo-endoscopic surgery
Key exclusion criteria
1. patient who have skin disease
2. patient who have metal allergy
3. patient who have experienced skin troubles by tape
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mototsugu |
| Middle name | |
| Last name | Oya |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
1600016
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
moto-oya@z3.keio.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Matsumoto |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
1600016
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
Homepage URL
kazz_matsumoto@yahoo.co.jp
Sponsor or person
Institute
Department of Urology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Keio University School of Medicine
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
Department of Urology, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
03-3353-1211
yabuyobi@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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 12 | 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
36
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
| 2014 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 12 | Day |
Last modified on
| 2020 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016240
