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 UMIN000007052
Receipt No. R000008279
Scientific Title A clinical study on Cine-MRI evaluation of intra-abdominal adhesion in patients after ulcerative colitis 3-staged operation
Date of disclosure of the study information 2012/02/01
Last modified on 2013/07/11

* 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 A clinical study on Cine-MRI evaluation of intra-abdominal adhesion in patients after ulcerative colitis 3-staged operation
Acronym A clinical study on Cine-MRI evaluation of intra-abdominal adhesion in patients after ulcerative colitis 3-staged operation
Scientific Title A clinical study on Cine-MRI evaluation of intra-abdominal adhesion in patients after ulcerative colitis 3-staged operation
Scientific Title:Acronym A clinical study on Cine-MRI evaluation of intra-abdominal adhesion in patients after ulcerative colitis 3-staged operation
Region
Japan

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

Objectives
Narrative objectives1 This study aims to evaluate the intra-abdominal adhesion by Cine-MRI images in the patients who underwent ulcerative colitis 3-staged operation, and to confirm that the evaluation results are equivalent to the intraoperative findings.
Basic objectives2 Others
Basic objectives -Others To confirm the effectiveness and validity of evaluation procedure of Cine-MRI for detecting intra-abdominal adhesions
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes (1) Cine-MRI evaluations and intraoperative findings of intra-abdominal adhesions
(2) Consistency between Cine-MRI evaluation results and intraoperative findings in the evaluation of intra-abdominal adhesion
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Intra-abdominal adhesion is evaluated by Cine-MRI before the second operation. Intra-abdominal adhesion is evaluated by laparoscopey at the second operation
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent the second operation of 3-staged operation for ulcerative colitis
(1) Patients who are expected to undergo open surgery for the second operation
(2) Patients aged 16 years or older at the time of informed consent
(3)Patients who can provide written informed consent
Key exclusion criteria (1)Patients who are expected to be difficult to receive the Cine-MRI scan before the second operation
(2)Patients who are expected to be difficult for evaluating the intra-abdominal adhesion at the second operation
(3)Patients who received unapproved drugs or treatments with unapproved medical devices within 16 weeks prior to informed consent
(4)Patients who have a previous history of allergy to iodine or iodinated contrast material
(5)Others who are judged to be unsuitable for inclusion in the study by the investigator or the co-investigators
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yuji Funayama
Organization Tohoku Rosai Hospital
Division name Department of colorectal surgery
Zip code
Address 4-3-21, Daihara , Aoba-ku Sendai, Miyagi, Japan
TEL 022-275-1111
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Yuji Funayama
Organization Tohoku Rosai Hospital
Division name Department of colorectal surgery
Zip code
Address 4-3-21, Daihara , Aoba-ku Senda
TEL 022-275-1111
Homepage URL
Email

Sponsor
Institute Tohoku Rosai Hospital
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2012 Year 02 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
2011 Year 11 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 05 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
2012 Year 01 Month 11 Day
Last modified on
2013 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008279

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.