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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023947
Receipt No. R000027572
Scientific Title Ingenious attempt of Seprafilm for temporary colostomy on pediatric anorectal malformations/Hirschsprung's disease/Allied disorders of Hirschsprung's disease
Date of disclosure of the study information 2016/09/06
Last modified on 2018/09/18

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Basic information
Public title Ingenious attempt of Seprafilm for temporary colostomy on pediatric anorectal malformations/Hirschsprung's disease/Allied disorders of Hirschsprung's disease
Acronym Ingenious attempt of Seprafilm for pediatric temporary colostomy
Scientific Title Ingenious attempt of Seprafilm for temporary colostomy on pediatric anorectal malformations/Hirschsprung's disease/Allied disorders of Hirschsprung's disease
Scientific Title:Acronym Ingenious attempt of Seprafilm for pediatric temporary colostomy
Region
Japan

Condition
Condition anorectal malformations/ Hirschsprung's disease/ Allied disorders of Hirschsprung's disease
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery Pediatrics
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Validation of operating time or amount of blood loss by the use Seprafilm around the intestine beneath the abdominal wall on temporary stoma for pediatric anorectal malformations/ Hirschsprung's disease/ Allied disorders of Hirschsprung's disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Degree of adhesion beneath the abdominal wall, operating time, amount of blood loss
Key secondary outcomes Complications after colostomy, incident rate of adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Put Seprafilm around the intestine beneath the abdominal wall on temporary colostomy for pediatric anorectal malformations/ Hirschsprung's disease/ Allied disorders of Hirschsprung's disease
Interventions/Control_2
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
0 years-old <=
Age-upper limit
7 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with stoma for anorectal malformations/ Hirschsprung's disease/ Allied disorders of Hirschsprung's disease
2) Patients with paper-based agreement to participate in this study
Key exclusion criteria 1) Patients with infection on the site planning to attach Seprafilm
2) Patients with past allergic history against component parts of Seprafilm
3) Others: the patients who are difficult to participate in this study (e.g. severe comorbidities)
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoaki Taguchi
Organization Kyushu University Hospital
Division name Pediatric surgery
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5573
Email taguchi@pedsurg.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Izaki
Organization Kyushu University Hospital
Division name Pediatric surgery
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5573
Homepage URL
Email izaki@pedsurg.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Kyushu University Hospital
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 06 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
2016 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 06 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
2016 Year 09 Month 06 Day
Last modified on
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027572

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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