UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009800 |
|---|---|
| Receipt number | R000010830 |
| Scientific Title | The effect of duration of antimicrobial prophylaxis on postoperative infectious complications after hepatobiliary resection with cholangiojejunostomy |
| Date of disclosure of the study information | 2013/01/18 |
| Last modified on | 2017/07/24 13:23:34 |
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Basic information
Public title
The effect of duration of antimicrobial prophylaxis on postoperative infectious complications after hepatobiliary resection with cholangiojejunostomy
Acronym
The effect of duration of antimicrobial prophylaxis on postoperative infectious complications after hepatobiliary resection with cholangiojejunostomy
Scientific Title
The effect of duration of antimicrobial prophylaxis on postoperative infectious complications after hepatobiliary resection with cholangiojejunostomy
Scientific Title:Acronym
The effect of duration of antimicrobial prophylaxis on postoperative infectious complications after hepatobiliary resection with cholangiojejunostomy
Region
| Japan |
Condition
Condition
Patients who are undergoing hepatobiliary resection with cholangiojejunostomy after preoperative biliary drainage
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation between the duration of antimicrobial prophylaxis and postoperative infectious complications in patients undergoing hepatobiliary resection with cholangiojejunostomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the occurrence of postoperative infectious complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administer antimicrobial prophylaxis for 2 days
Interventions/Control_2
administer antimicrobial prophylaxis for 4 days
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
With preoperative biliary drainage
Key exclusion criteria
hepatopancreatic resection
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nagino Masato |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
Address
65 Tsurumai Showa-ku Nagoya city Japan
TEL
052-744-2222
nagino@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sugawara Gen |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
Address
65 Tsurumai Showa-ku Nagoya city Japan
TEL
052-744-2222
Homepage URL
gsuga@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine Division of Surgical Oncology, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine Division of Surgical Oncology, 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
Address
Tel
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
名古屋大学附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Now we are ready to start trial.
Management information
Registered date
| 2013 | Year | 01 | Month | 17 | Day |
Last modified on
| 2017 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010830
