UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032174 |
|---|---|
| Receipt number | R000036706 |
| Scientific Title | Multicenter randomized Phase two study on effectiveness of negative pressure wound therapy for the wound of ileostomy closure |
| Date of disclosure of the study information | 2018/04/10 |
| Last modified on | 2019/12/08 21:33:20 |
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Basic information
Public title
Multicenter randomized Phase two study on effectiveness of negative pressure wound therapy for the wound of ileostomy closure
Acronym
NPWT study for ileostomy closure
Scientific Title
Multicenter randomized Phase two study on effectiveness of negative pressure wound therapy for the wound of ileostomy closure
Scientific Title:Acronym
NPWT study for ileostomy closure
Region
| Japan |
Condition
Condition
the wound of ileostomy closure
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and optimal period of negative pressure wound therapy for ileostomy closure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
reduction rate of wound volume
Key secondary outcomes
rate of wound infection, wound size, pain, wound healing period, rate of complication except for wound infection
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
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
pursestring wound closure + negative pressure wound therapy for one week
Interventions/Control_2
pursestring wound closure + negative pressure wound therapy for two weeks
Interventions/Control_3
pursestring wound closure
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
patients of ileostomy closure
Key exclusion criteria
FAP or IBD, uncontrolled DM, taking steroids, dementia, mental disease, postoperative delirium
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimihiko Funahashi |
Organization
Toho University Omori Medical Center
Division name
colorectal surgery
Zip code
Address
6-11-1 Omorinishi Ota-ku Tokyo
TEL
03-3762-4151
kingkong@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Kojima |
Organization
Kyorin University Hospital
Division name
general and digestive surgery
Zip code
Address
6-20-2 Shinkawa Mitaka-shi Tokyo
TEL
0422-47-5511
Homepage URL
k-kojikoji@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Teikyo University Hospital, Jukei University Hospital, Toho University Ohashi Medical Center, Jyuntendo University Hospital
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
東邦大学医療センター大橋病院（東京都）、帝京大学医学部附属病院（東京都）、東京慈恵会医科大学附属病院（東京都）、東邦大学医療センター大森病院（東京都）、順天堂大学病院（東京都）、杏林大学医学部付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 10 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 10 | Day |
Last modified on
| 2019 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036706
