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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030936
Receipt No. R000035332
Scientific Title A randomized phase II study to evaluate efficacy of negative pressure wound therapy on prophylaxis of the incisional hernia after reversal of temporaly diverting stoma
Date of disclosure of the study information 2018/01/22
Last modified on 2019/07/25

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Basic information
Public title A randomized phase II study to evaluate efficacy of negative pressure wound therapy on prophylaxis of the incisional hernia after reversal of temporaly diverting stoma
Acronym Negative pressure wound therapy on the prophylaxis of the incisional hernia
Scientific Title A randomized phase II study to evaluate efficacy of negative pressure wound therapy on prophylaxis of the incisional hernia after reversal of temporaly diverting stoma
Scientific Title:Acronym Negative pressure wound therapy on the prophylaxis of the incisional hernia
Region
Japan

Condition
Condition temporally diverting stoma to be planned to have closed
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy of negative pressure wound therapy on prevention of the incisional hernia after reversal of temporally diverting stoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes rate of incidence of radiological incisional hernia after one year of surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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
Device,equipment
Interventions/Control_1 Negative Pressure Wound Therapy for seven to eight days
Interventions/Control_2 standard stoma reversal
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients with temporally stoma to be planned to have closed who had received initial surgery at our institution
Key exclusion criteria severe skin disease
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Shunichiro
Middle name
Last name Komatsu
Organization Aichi Medical University
Division name Gastroenterological Surgery
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL 0561-62-3311
Email skomat2718@gmail.com

Public contact
Name of contact person
1st name Shunichiro
Middle name
Last name Komatsu
Organization Aichi Medical University
Division name Gastroenterological Surgery
Zip code 480-1195
Address 1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL 0561-62-3311
Homepage URL
Email skomat2718@gmail.com

Sponsor
Institute Aichi Medical University
Institute
Department

Funding Source
Organization Self funding
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 Aichi Medical University ethical committee
Address 1-1 Yazakokarimata, Nagakute, Aichi, Japan
Tel 0561-62-3311
Email amu_ethics@aichi-med-u.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
2018 Year 01 Month 22 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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 06 Day
Date of IRB
2018 Year 01 Month 22 Day
Anticipated trial start date
2018 Year 01 Month 22 Day
Last follow-up date
2021 Year 12 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
2018 Year 01 Month 22 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035332

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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