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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012868
Receipt No. R000015034
Scientific Title Usefulfulness and safety of Endoscopic internal abcess drainage(EIAD) for appendiceal abcess
Date of disclosure of the study information 2014/01/16
Last modified on 2017/01/18

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Basic information
Public title Usefulfulness and safety of Endoscopic internal abcess drainage(EIAD) for appendiceal abcess
Acronym Endoscopic internal abcess drainage(EIAD) for appendiceal abcess
Scientific Title Usefulfulness and safety of Endoscopic internal abcess drainage(EIAD) for appendiceal abcess
Scientific Title:Acronym Endoscopic internal abcess drainage(EIAD) for appendiceal abcess
Region
Japan

Condition
Condition appendiceal abcess
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 for consider about the usefulness and safety of Endoscopic intraluminal abcess drainage for appendiceal abcess
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes compared to the length of hospital stay of past cases in Retrospective
Key secondary outcomes

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 Maneuver
Interventions/Control_1 We insert a drainage tube into the appendix orifice endoscopically
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
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria all of the appendiceal abcess
Key exclusion criteria (1)Patients over the age of 75
(2)Patients using immunosuppressive drugs and steroids
(3)Diabetes
(4)Bleeding tendency (coagulation abnormalities)
(5)Patient physician-deemed inappropriate
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehito Otsubo
Organization St. Marianna University School of Medicine
Division name Division of Gastroenterological and General Surgery
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL 044-977-8111
Email otsubo@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinjiro Kobayashi
Organization St. Marianna University School of Medicine
Division name Division of Gastroenterological and General Surgery
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL 044-977-8111
Homepage URL
Email koharubiyori@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization no
Organization
Division
Category of Funding Organization Other
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
2014 Year 01 Month 16 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
2013 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 30 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
2014 Year 01 Month 16 Day
Last modified on
2017 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015034

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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