UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003611 |
|---|---|
| Receipt number | R000004377 |
| Scientific Title | A clinical research on evaluation of Intra-Abdominal Adhesion of the post-gastrointestinal surgery patients |
| Date of disclosure of the study information | 2010/05/14 |
| Last modified on | 2010/09/30 17:26:58 |
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Basic information
Public title
A clinical research on evaluation of Intra-Abdominal Adhesion of the post-gastrointestinal surgery patients
Acronym
A clinical research on evaluation of Intra-Abdominal Adhesion of the post-gastrointestinal surgery patients
Scientific Title
A clinical research on evaluation of Intra-Abdominal Adhesion of the post-gastrointestinal surgery patients
Scientific Title:Acronym
A clinical research on evaluation of Intra-Abdominal Adhesion of the post-gastrointestinal surgery patients
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the intra-abdominal adhesion of the post-gastrointestinal surgery patients by the Endoscope, and Recorded in the image. In addition, It's classified according to the state.
Basic objectives2
Others
Basic objectives -Others
The confirmation of the adhesion state in the abdominal cavity and confirmation of the clinical validity of evaluation system of the adhesion
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Image of intra-abdominal adhesion
(2) Classification of intra-abdominal adhesion according to adhesion-range
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 | Maneuver |
Interventions/Control_1
A Intra-abdominal adhesion is observed at Laparoscopic or endoscopic surgery of ileum colostomy close
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
(1) Patients not under 20 years old at time of informed consent
(2)Patients providing written informed consent
Key exclusion criteria
(1)Patients with not safety observation by endoscope at operation
(2)Patients who received a unapproved drugs or a unapproved medical device without 16 weeks from informed consent day
(3)Others, patients who judged not competent by researcher of responsibility or those
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Ikeuchi |
Organization
Hyogo College Of Medicine
Division name
Department of surgery
Zip code
Address
1-1,Mukogawa-cho,Nishinomiya-city,Hyogo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Ikeuchi |
Organization
Hyogo College Of Medicine
Division name
Department of surgery
Zip code
Address
1-1,Mukogawa-cho,Nishinomiya-city,Hyogo
TEL
0798-45-6372
Homepage URL
Sponsor or person
Institute
Hyogo College Of Medicine
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
兵庫医科大学（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 14 | 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
| 2010 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 13 | Day |
Last modified on
| 2010 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004377
