UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004879 |
|---|---|
| Receipt number | R000005809 |
| Scientific Title | A clinical research on evaluation of intra-abdominal adhesion of the post-gastrointestinal surgery patients |
| Date of disclosure of the study information | 2011/01/21 |
| Last modified on | 2014/01/14 09:53:11 |
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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
colorectal disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the verification of observe and evaluate the intra-abdominal adhesion by the laparoscope, a method of single port with positive postural change.
Basic objectives2
Others
Basic objectives -Others
The confirmation of the clinical validity of observation and evaluation system of the intra-abdominal adhesion
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Verification of observe and evaluate the intra-abdominal adhesion by the laparoscope
Key secondary outcomes
Evaluation of intra-abdominal adhesion
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
| Maneuver |
Interventions/Control_1
A Intra-abdominal adhesion is observed at Laparoscopic 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)Patients who judged not competent by researcher of responsibility or those
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshimitsu Araki |
Organization
Mie University Hospital
Division name
Center of maternal and child health
Zip code
Address
2-174 Edobashi, Tsu, Mie, JAPAN
TEL
059-232-1111
taraki@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshimitsu Araki |
Organization
Mie University Hospital
Division name
Center of maternal and child health
Zip code
Address
2-174 Edobashi, Tsu, Mie, JAPAN
TEL
059-232-1111
Homepage URL
taraki@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Gastrointestinal Surgery, Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
三重大学医学部附属病院（三重県）
Mie University Hospital（Mie）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 21 | 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
Suspended
Date of protocol fixation
| 2010 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 14 | Day |
Last modified on
| 2014 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005809
