UMIN-CTR Clinical Trial

Basic information
Public title	Incidence and risk factor of outlet obstruction after construction of ileostomy
Acronym	Risk factor of outlet obstruction
Scientific Title	Incidence and risk factor of outlet obstruction after construction of ileostomy
Scientific Title:Acronym	Risk factor of outlet obstruction
Region	Japan

Condition
Condition	Ulcerative colitis, Familiar adenomatous polyposis, rectal cancer, etc
Classification by specialty	Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the frequency and risk factors of outlet obstruction after construction of ileostomy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Risk factors of outlet obstruction after construction of ileostomy.
Key secondary outcomes	Incidence of outlet obstruction after construction of ileostomy.

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
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Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients those who were constructed ileostomy at Chiba university Hospital between January 2010 to December 2015. 2) Presence of detailed surgical record
Key exclusion criteria	1) Patients who died within 30 days after surgery 2) Patients who died without being able to ingest orally even at once after surgery
Target sample size	107

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hisahiro Matsubara
Organization	Graduate school of medicine, Chiba University
Division name	Department of frontier surgery
Zip code
Address	1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken
TEL	043-226-2110
Email	matsuhm@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Middle name Last name Gaku ohira
Organization	Graduate school of medicine, Chiba University
Division name	Department of frontier surgery
Zip code
Address	1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken
TEL	043-226-2110
Homepage URL
Email	Ohira@faculty.chiba-u.jp

Sponsor
Institute	Graduate school of medicine, Chiba University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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	2017 Year 07 Month 01 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
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
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IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date	2017 Year 02 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We accumulated data of 107 cases as planned.

Management information
Registered date	2017 Year 07 Month 01 Day
Last modified on	2017 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032099

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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