UMIN-CTR Clinical Trial

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
Email	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
Email	k-furukawa@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050774