UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035755 |
|---|---|
| Receipt number | R000040672 |
| Scientific Title | The effect of adhesion prevention absorbing barrier wrapping method for temporary ileostomy creation |
| Date of disclosure of the study information | 2019/02/06 |
| Last modified on | 2023/03/03 14:21:37 |
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Basic information
Public title
The effect of adhesion prevention absorbing barrier wrapping method for temporary ileostomy creation
Acronym
The effect of adhesion prevention absorbing barrier wrapping method for temporary ileostomy creation
Scientific Title
The effect of adhesion prevention absorbing barrier wrapping method for temporary ileostomy creation
Scientific Title:Acronym
The effect of adhesion prevention absorbing barrier wrapping method for temporary ileostomy creation
Region
| Japan |
Condition
Condition
colorectal carcinoma
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the adhesion preventing effect by wrapping sodium hyaluronate / carboxymethyl cellulose adhesion preventing absorbable barrier (Seprafilm) on ileostomy at the time of constructing temporary ileostomy in laparoscopic colon resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of adhesion around ileostomy
Key secondary outcomes
The extent and extent of adhesion around the ileostomy
operative time during ileostomy closure
Bleeding volume
hospital stay after ileostomy closure
Adverse event
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Wrap a seprafilm around the ileum when constructing temporary ileostomy.
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) Laparoscopic colon resection or rectal resection with robot assistance involving temporary ileostomy is planned
2) Age is over 20 years old
3) ECOG's Performance Status (PS) is 0 - 1
4) Document consent has been obtained
Key exclusion criteria
Case in which infection is observed at the site to which the Seprafilm is to be applied
Patients with a history of hypersensitivity to components of Seprafilm.
Cases with severe liver disease.
Cases with severe kidney disease.
Pregnant women, possible cases of pregnancy.
Other cases that the physician judged as maladaptive.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takemasa |
Organization
Sapporo medical university hospital
Division name
Department of Surgery,Surgical Oncology and Science
Zip code
060-8556
Address
nishi 16 choume minami 1 jyo Chuo-ku Sapporo
TEL
011-611-2111
okuya@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Okuya |
Organization
Sapporo medical university
Division name
Department of Surgery,Surgical Oncology and Science
Zip code
060-8556
Address
nishi 16 choume minami 1 jyo Chuo-ku Sapporo
TEL
011-611-2111
Homepage URL
okuya@sapmed.ac.jp
Sponsor or person
Institute
Sapporo medical university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo medical university hospital institutional review board
Address
nishi 16 choume minami 1 jyo Chuo-ku Sapporo
Tel
011-611-2111
ji-rskk@sapmed.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
| 2019 | Year | 02 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 03 | Day |
Last modified on
| 2023 | 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=R000040672
