UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044443 |
|---|---|
| Receipt number | R000050774 |
| Scientific Title | Risk factors and overcoming strategies of surgical site infection after liver resection for colorectal liver metastases : A retrospective cohort study |
| Date of disclosure of the study information | 2021/06/05 |
| Last modified on | 2021/06/05 14:43:57 |
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Basic information
Public title
Risk factors and overcoming strategies of surgical site infection after liver resection for colorectal liver metastases : A retrospective cohort study
Acronym
Risk factors and overcoming strategies of surgical site infection after liver resection for colorectal liver metastases : A retrospective cohort study
Scientific Title
Risk factors and overcoming strategies of surgical site infection after liver resection for colorectal liver metastases : A retrospective cohort study
Scientific Title:Acronym
Risk factors and overcoming strategies of surgical site infection after liver resection for colorectal liver metastases : A retrospective cohort study
Region
| Japan |
Condition
Condition
Colorectal liver metastases (CRLM)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate risk factors of SSI in patients who underwent liver resection for CRLM and to establish methods to reduce the prevalence of SSI which may lead to improved prognosis.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to investigate risk factors of SSI in patients who underwent liver resection for CRLM and to establish methods to reduce the prevalence of SSI which may lead to improved prognosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of SSI
Key secondary outcomes
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
| 28 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Between May 2007 and March 2020, 151 consecutive patients with CRLM who underwent an initial liver resection.
Key exclusion criteria
Staged hepatectomies.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Ikegami |
Organization
The Jikei University School of Medicine
Division name
Division of Hepatobiliary and Pancreas Surgery, Department of Surgery
Zip code
105-8461
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
toruikegamijikei@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Kenei |
| Middle name | |
| Last name | Furukawa |
Organization
The Jikei University School of Medicine
Division name
Division of Hepatobiliary and Pancreas Surgery, Department of Surgery
Zip code
105-8461
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
Homepage URL
k-furukawa@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
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
the Ethics Committee of the Jikei University School of Medicine
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
03-3433-1111
rinri@jikei.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
| 2021 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
151
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
Main results already published
Date of protocol fixation
| 2020 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 01 | 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
We investigated the relationship between the patient characteristics and perioperative factors and the incidence of SSI.
Management information
Registered date
| 2021 | Year | 06 | Month | 05 | Day |
Last modified on
| 2021 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050774
