UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030936 |
|---|---|
| Receipt number | 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 | 2022/01/26 14:02:49 |
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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
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
skomat2718@gmail.com
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
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
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
| 2023 | 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
| 2022 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035332
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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