UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001278 |
|---|---|
| Receipt number | R000001555 |
| Scientific Title | Randomized clinical trial attesting the effectiveness of perioperative antimicrobial agents according to the result of preoperative bile culture in patients undergoing biliary reconstruction. |
| Date of disclosure of the study information | 2008/08/01 |
| Last modified on | 2013/09/09 19:29:12 |
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Basic information
Public title
Randomized clinical trial attesting the effectiveness of perioperative antimicrobial agents according to the result of preoperative bile culture in patients undergoing biliary reconstruction.
Acronym
RCT on perioperative antimicrobial therapy in biliary surgery.
Scientific Title
Randomized clinical trial attesting the effectiveness of perioperative antimicrobial agents according to the result of preoperative bile culture in patients undergoing biliary reconstruction.
Scientific Title:Acronym
RCT on perioperative antimicrobial therapy in biliary surgery.
Region
| Japan |
Condition
Condition
Hepato-biliary-pancreatic diseases
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this randomized clinical trial is to determine whether therapeutic usage of antimicrobial agents according to the result of preoperative bile culture in patients undergoing the biliary reconstruction treated as Class3 (contaminated) by CDC (Centers for Disease Control and Prevention) guideline during the perioperative period can reduce surgical site infection (SSI) occurrence rates compared with prophylactic usage of antimicrobial agents recommended by CDC guideline as Class2 (clean-contaminated).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the incidence of SSI occurrence rates within postoperative 30 days between 2 groups (therapeutic usage of antimicrobial agents treated as Class3 by CDC guideline and prophylactic usage of antimicrobial agents recommended by CDC guideline as Class2).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antimicrobial prophylaxis (second-generation cephalosporin) are administered for three days in perioperative period recommended by CDC guideline as Class2.
Interventions/Control_2
Therapeutic antimicrobial agents according to the result of preoperative bile culture are administered for three days in perioperative period treated as Class3 by CDC guideline.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Males and females over 18 years old, and with hepatobiliary and pancreatic diseases who have undergone external biliary drainage (endoscopic nasobiliary drainage: ENBD or percutaneous transhepatic biliary drainage: PTBD) before operation.
Key exclusion criteria
Patients with renal dysfunction, sever liver dysfunction or a history of antimicrobial agents -induced allergy.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Hirano |
Organization
Hokkaido university hospital
Division name
Gastroenterological sutgery II
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo Japan
TEL
011-716-1161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunishige Okamura |
Organization
Hokkaido university hospital
Division name
Gastroenterological sutgery II
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo Japan
TEL
Homepage URL
Sponsor or person
Institute
Hokkaido university hospital gastroenterological sutgery II
Institute
Department
Personal name
Funding Source
Organization
Hokkaido university hospital gastroenterological sutgery II
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2008 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 07 | Month | 30 | Day |
Last modified on
| 2013 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001555
| Research Plan | |
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| 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 |
