UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028287 |
|---|---|
| Receipt number | R000032381 |
| Scientific Title | Investigation on the effect of changing surgical insturament on postoperative wound infection of Intestinal disease |
| Date of disclosure of the study information | 2017/08/26 |
| Last modified on | 2023/01/26 08:57:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation on the effect of changing surgical insturament on postoperative wound infection of Intestinal disease
Acronym
The effect of changing surgical insturament on postoperative wound infection of Intestinal disorders
Scientific Title
Investigation on the effect of changing surgical insturament on postoperative wound infection of Intestinal disease
Scientific Title:Acronym
The effect of changing surgical insturament on postoperative wound infection of Intestinal disorders
Region
| Japan |
Condition
Condition
Lower gastrointestinal surgery operation
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
SSI in gastrointestinal surgery is an important complication.Currently, our hospital uses a closed wound surgical insturament, but there is no clear evidence of the impact of the wound on SSI after surgery. We examined the influence of the use of the wound closure surgical insturament on postoperative wound infection of the lower gastrointestinal surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Infection rate
Postoperative hospital stay
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Changed the insutrament for wound close
Interventions/Control_2
Not Changed the insutrament for wound close
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Lower gastrointestinal surgery performed in our department
Key exclusion criteria
other than that
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Ryuichi |
| Middle name | |
| Last name | Kuwahara |
Organization
Hyogo College of Medicine
Division name
Inflammatory bowel disease surgery
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture
TEL
0798-45-6372
kuwahararyuichi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | ryuichi |
| Middle name | |
| Last name | Kuwahara |
Organization
Hyogo College of Medicine
Division name
Inflammatory bowel disease surgery
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture
TEL
0798-45-6372
Homepage URL
kuwahararyuichi@yahoo.co.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
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
Hyogo College of Medicine
Address
1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture
Tel
08014641854
kuwahararyuichi@yahoo.co.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 | 08 | Month | 26 | 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
| Delay expected |
Results Delay Reason
Due to the time required for necessary work due to the COVID-19 outbreak
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 19 | Day |
Last modified on
| 2023 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032381
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
