UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040776
Receipt number R000046565
Scientific Title Risk Factors for Surgical site infection After Pancreatectomy and the Associated Pathogens; a Retrospective Case-controlled Study
Date of disclosure of the study information 2020/06/15
Last modified on 2020/06/15 23:50:43

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Basic information

Public title

Risk Factors for Surgical site infection After Pancreatectomy and the Associated Pathogens; a Retrospective Case-controlled Study

Acronym

Pathogens Examination From Drainage Fluid After Pancreatectomy

Scientific Title

Risk Factors for Surgical site infection After Pancreatectomy and the Associated Pathogens; a Retrospective Case-controlled Study

Scientific Title:Acronym

Pathogens Examination From Drainage Fluid After Pancreatectomy

Region

Japan


Condition

Condition

Pancreatectomy

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to assess the risk factors for postoperative pancreatic fistula, to identify pathogen profiles cultured from postoperative drainage fluids, and to evaluate the predictability of high-risk pathogens for severe complications.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the incidence of clinically relevant postoperative pancreatic fistula

Key secondary outcomes

the types and the frequencies of microorganisms as related to the severity of the clinically relevant postoperative pancreatic fistula


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

100 years-old >

Gender

Male and Female

Key inclusion criteria

patients who underwent pancreaticoduodenectomy or distal pancreatectomy

Key exclusion criteria

patients who underwent total pancreatectomy or partial pancreatic resection

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Minoru
Middle name
Last name Kitago

Organization

Keio University School of Medicine

Division name

Department of Surgery

Zip code

1608582

Address

Shinanomachi 35, Shinjuku-ku, Tokyo, Japan

TEL

+81-3-5363-3802

Email

dragonpegasus@keio.jp


Public contact

Name of contact person

1st name Kodai
Middle name
Last name Abe

Organization

Keio University School of Medicine

Division name

Department of Surgery

Zip code

1608582

Address

Shinanomachi 35, Shinjuku-ku, Tokyo, Japan

TEL

+81-3-5363-3802

Homepage URL


Email

abe.kodai@gmail.com


Sponsor or person

Institute

Keio University School of Medicine, Department of Surgery

Institute

Department

Personal name



Funding Source

Organization

Keio University School of Medicine, Department of Surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine, An Ethics Committee

Address

Shinanomachi 35, Shinjuku-ku, Tokyo

Tel

+81-3-5363-3611

Email

med-rinri-jimu@adst.keio.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

2020 Year 06 Month 15 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

429

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

2019 Year 04 Month 10 Day

Date of IRB

2012 Year 04 Month 03 Day

Anticipated trial start date

2019 Year 05 Month 10 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective case-controlled study


Management information

Registered date

2020 Year 06 Month 15 Day

Last modified on

2020 Year 06 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046565


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name