UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012334
Receipt No. R000014356
Scientific Title Clinical trial of ostomy creation with tissue adhesives.
Date of disclosure of the study information 2013/12/01
Last modified on 2016/09/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical trial of ostomy creation with tissue adhesives.
Acronym Ostomy creation with tissue adhesives.
Scientific Title Clinical trial of ostomy creation with tissue adhesives.
Scientific Title:Acronym Ostomy creation with tissue adhesives.
Region
Japan

Condition
Condition Inflammatory bowel disease
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safty of ostomy creation with tissue adhesives in phase 1 trial.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Early complications in ostomy creation which include wound dehiscence and collapse
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Tissue adhesives
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with inflammatory bowel disease who need ostomy creation in surgical procedure.
Key exclusion criteria Obesity (Body mass indexs are higher than 25.
Emergent surgery.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoi Uchino
Organization Hyogo college of medicine
Division name Lower gastroenterological surgery
Zip code
Address 1-1, Mukogawacho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6371
Email motoi.uchino@nifty.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoi Uchino
Organization Hyogo college of medicine
Division name Lower gastroenterological surgery
Zip code
Address 1-1, Mukogawacho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6371
Homepage URL
Email motoi.uchino@nifty.ne.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

Funding Source
Organization Hyogo college of medicine
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
2013 Year 12 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
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 Completed
Date of protocol fixation
2013 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 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
2013 Year 11 Month 18 Day
Last modified on
2016 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014356

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.