UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037690 |
|---|---|
| Receipt number | R000042982 |
| Scientific Title | Evaluation of patient satisfaction with skin adhesive (Liquiband) for wounds after gynecological laparoscopic surgery, randomized controlled trial with hydrocolloid preparation (Clear Hessive) |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2019/08/15 02:09:01 |
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Basic information
Public title
Evaluation of patient satisfaction with skin adhesive (Liquiband) for wounds after gynecological laparoscopic surgery, randomized controlled trial with hydrocolloid preparation (Clear Hessive)
Acronym
Evaluation of patient satisfaction with skin adhesive for wounds after gynecological laparoscopic surgery
Scientific Title
Evaluation of patient satisfaction with skin adhesive (Liquiband) for wounds after gynecological laparoscopic surgery, randomized controlled trial with hydrocolloid preparation (Clear Hessive)
Scientific Title:Acronym
Evaluation of patient satisfaction with skin adhesive for wounds after gynecological laparoscopic surgery
Region
| Japan |
Condition
Condition
leiomyomas or benign ovarian tumors
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improving patient satisfaction at the wound after laparoscopic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
patient satisfaction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Skin adhesive
Interventions/Control_2
Hydrocolloid formulation
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Patients scheduled to undergo laparoscopic surgery for leiomyomas or ovarian benign tumors
Key exclusion criteria
Pregnant or diabetic
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Ozaki |
Organization
Juntendo University Faculty of Medicine
Division name
Obstetrics and Gynecology
Zip code
1138421
Address
2-1-1 Hongo, Bunkyo-ku
TEL
0338133111
rieozaki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Ozaki |
Organization
Juntendo University Faculty of Medicine
Division name
Obstetrics and Gynecology
Zip code
1138421
Address
2-1-1 Hongo, Bunkyo-ku
TEL
0338133111
Homepage URL
rieozaki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Faculty of Medicine
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
Juntendo University Faculty of Medicine
Address
2-1-1 Hongo, Bunkyo-ku
Tel
0338133111
rieozaki@juntendo.ac.jp
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
| 2019 | Year | 09 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 15 | Day |
Last modified on
| 2019 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042982
