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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012961
Receipt No. R000015123
Scientific Title the forward comparative study about the effect of the new closed-type drainage system in the drainage in the abdominal cavity after a gastrointestinal operation
Date of disclosure of the study information 2014/01/27
Last modified on 2014/01/26

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Basic information
Public title the forward comparative study about the effect of the new closed-type drainage system in the drainage in the abdominal cavity after a gastrointestinal operation
Acronym the comparative study about the effect of the new closed-type drainage system
Scientific Title the forward comparative study about the effect of the new closed-type drainage system in the drainage in the abdominal cavity after a gastrointestinal operation
Scientific Title:Acronym the comparative study about the effect of the new closed-type drainage system
Region
Japan

Condition
Condition esophageal cancer, gastric cancer, rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Comparison of the influence that the difference of a shape and the materials of the drain gives to infection frequency after quantity of waste fluid after operation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes surgical site infection
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria esophageal cancer,gastric cancer,rectal cancer
Key exclusion criteria emergency operation
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Uchiyama Kazuhisa
Organization Osaka Medical College
Division name Departments of General and Gastroenterological Surgery
Zip code
Address 2-7, Daigakumachi, Takatsuki-city, Osaka prefecture
TEL 072-683-1221
Email uchi@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ishii Masatsugu
Organization Osaka Medical College
Division name Departments of General and Gastroenterological Surgery
Zip code
Address 2-7, Daigakumachi, Takatsuki-city, Osaka prefecture
TEL 072-683-1221
Homepage URL
Email sur151@poh.osaka-med.ac.jp

Sponsor
Institute Departments of General and Gastroenterological Surgery
Institute
Department

Funding Source
Organization COVIDIEN
Organization
Division
Category of Funding Organization Profit organization
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 大阪医科大学附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 27 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 Preinitiation
Date of protocol fixation
2014 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We distribte patiens to a MCDS group and a Silicon group post gastrointesital tract surgery, and we evaluate some factors.

Management information
Registered date
2014 Year 01 Month 26 Day
Last modified on
2014 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015123

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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