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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032174
Receipt No. 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 2018/04/10

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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
Email 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
Email k-kojikoji@ks.kyorin-u.ac.jp

Sponsor
Institute Toho University Omori Medical Center
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 10 Day
Last modified on
2018 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036706

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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