UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044124 |
|---|---|
| Receipt number | R000050386 |
| Scientific Title | Selection of sutures for wound infection prevention and cost reduction |
| Date of disclosure of the study information | 2021/05/07 |
| Last modified on | 2021/05/06 23:33:25 |
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Basic information
Public title
Selection of sutures for wound infection prevention and cost reduction
Acronym
Selection of sutures for wound infection prevention and cost reduction
Scientific Title
Selection of sutures for wound infection prevention and cost reduction
Scientific Title:Acronym
Selection of sutures for wound infection prevention and cost reduction
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will compare and examine the incidence of wound infection due to changes in the abdominal wall suture, and also consider reducing medical costs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative wound infection incidence
Key secondary outcomes
Postoperative hospital stay, cost reduction effect, late complications
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 undergoing elective colorectal cancer surgery
Key exclusion criteria
Minors under the age of 20
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Masaji |
| Middle name | |
| Last name | Tani |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu-city, Shiga
TEL
0775-48-2238
hqsurge1@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Terada |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu-city, Shiga
TEL
0775-48-2238
Homepage URL
teradayo@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
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
Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu-city, Shiga
Tel
077-548-3576
hqrec@belle.shiga-med.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
滋賀医科大学病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 07 | 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
| 2017 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Age, gender, BMI, underlying disease, tumor localization, clinical stage, preoperative test results (Hb, Alb, HbA1c, PNI) of patients who underwent elective colorectal cancer surgery at our hospital after January 2012, Surgical time, bleeding volume, postoperative complications, etc., to compare the incidence of wound infection before and after abdominal wall suture change, risk factors, preventive methods, and reduce medical costs consider.
Management information
Registered date
| 2021 | Year | 05 | Month | 06 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050386
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
