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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000004879
Receipt No. 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

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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
Email 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
Email taraki@clin.medic.mie-u.ac.jp

Sponsor
Institute Department of Gastrointestinal Surgery, Mie University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005809

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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