UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023750
Receipt No. R000023751
Scientific Title Association between outlet obstruction and ostomy site during restorative proctocolectomy in patients with ulcerative colitis.
Date of disclosure of the study information 2016/08/24
Last modified on 2018/11/30

* 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 Association between outlet obstruction and ostomy site during restorative proctocolectomy in patients with ulcerative colitis.
Acronym Association between outlet obstruction and ostomy site in UC surgery.
Scientific Title Association between outlet obstruction and ostomy site during restorative proctocolectomy in patients with ulcerative colitis.
Scientific Title:Acronym Association between outlet obstruction and ostomy site in UC surgery.
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the association between outlet obstruction and ostomy site during restorative proctocolectomy in patients with ulcerative colitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Prevalence of the outlet obstruction after ostomy creation.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 The ostomy create at the right lower quadrant abdominal wall.
Interventions/Control_2 The ostomy create at the left lower quadrant abdominal wall.
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
15 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patinets with ulcerative colitis who need proctocolectomy with ileal-pouch anal anastomosis and diverting ileostomy.
Key exclusion criteria Patients without agreement.
Patients whose intestine will be expect to twist at already determined ostomy site.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Ikeuchi
Organization Hyogo College of Medicine
Division name Dept of Inflammatory Bowel Disease
Zip code
Address 1-1 Mukogawacho, Nishinomiya, Hyogo
TEL 0798-45-6371
Email ikeuci2s@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoi Uchino
Organization Hyogo College o medicine
Division name Dept of Inflammatory Bowel Disease
Zip code
Address 1-1 Mukogawacho, Nishinomiya, Hyogo
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
2016 Year 08 Month 24 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
2016 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Before study

Management information
Registered date
2016 Year 08 Month 24 Day
Last modified on
2018 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023751

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.