UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of ostomy creation with tissue adhesives.
Title of the study (Brief title)	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	Motoi Uchino
Organization	Hyogo college of medicine
Division name	Lower gastroenterological surgery
Address	1-1, Mukogawacho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6371
Email	motoi.uchino@nifty.ne.jp

Public contact
Name of contact person	Motoi Uchino
Organization	Hyogo college of medicine
Division name	Lower gastroenterological surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014356