UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007052 |
|---|---|
| Receipt number | 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 12:00:42 |
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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
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
Public contact
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
Sponsor or person
Institute
Tohoku Rosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008279
