UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025886 |
|---|---|
| Receipt number | R000028126 |
| Scientific Title | Observational study for frequency and severity of postoperative intra-abdominal adhesion |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2020/03/03 19:53:03 |
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Basic information
Public title
Observational study for frequency and severity of postoperative intra-abdominal adhesion
Acronym
Observational study for frequency and severity of postoperative intra-abdominal adhesion
Scientific Title
Observational study for frequency and severity of postoperative intra-abdominal adhesion
Scientific Title:Acronym
Observational study for frequency and severity of postoperative intra-abdominal adhesion
Region
| Japan |
Condition
Condition
postoperative intra-abdominal adhesion
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the frequency and severity of postoperative intra-abdominal adhesion site.
Basic objectives2
Others
Basic objectives -Others
Epidemiological research
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the site and severity of postoperative intra-abdominal adhesion
Key secondary outcomes
the frequency of complications associated with postoperative intra-abdominal adhesion
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who fills everything the
following
(1)Patients with diverting ileostomy who are undergone stoma closure
(2)Patients who are able to provide written informed consent
Key exclusion criteria
(1)Patients who are not eligible due to physician's judgment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Okabayashi |
Organization
Keio University School of Medicine
Division name
Departement of Surgery
Zip code
160-8582
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan
TEL
0353633800
matsu10oka23@gmail.com
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Okabyashi |
Organization
Keio University School of Medicine
Division name
Departement of Surgery
Zip code
160-8582
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan
TEL
0353633800
Homepage URL
matsu10oka23@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
| 2017 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The observation of intra-abdominal adhesion by using laparoscopy when we perform stoma closure for diverting ileostomy.
Management information
Registered date
| 2017 | Year | 01 | Month | 27 | Day |
Last modified on
| 2020 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028126
