UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003749 |
|---|---|
| Receipt number | R000004528 |
| Scientific Title | Role of Prophylactic Antibiotics in Laparoscopic Cholecystectomy: A Prospective Randomized Study |
| Date of disclosure of the study information | 2010/06/14 |
| Last modified on | 2014/11/10 10:11:16 |
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Basic information
Public title
Role of Prophylactic Antibiotics in Laparoscopic Cholecystectomy: A Prospective Randomized Study
Acronym
Prophylactic antibiotics in laparoscopic cholecystectomy
Scientific Title
Role of Prophylactic Antibiotics in Laparoscopic Cholecystectomy: A Prospective Randomized Study
Scientific Title:Acronym
Prophylactic antibiotics in laparoscopic cholecystectomy
Region
| Japan |
Condition
Condition
Gallstone, Gallbladder polyp
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prophylactic antibiotics are routinely used with laparoscopic cholecystectomy. However, surgical infections relating to laparoscopic cholecystectomy appear to be infrequent because this minimally invasive surgery creates only a small wound. To estimate whether prophylactic antibiotics are necessary for laparoscopic cholecystectomy, we began a randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
postoperative infection-related complications
Key secondary outcomes
postoperative hospital stay
postoperative medical costs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Antibiotic group: First generation cefem (1.0 g/body) is infused once intraoperatively and twice on postoperative day 1.
Interventions/Control_2
No antibiotic group: No perioperative antibiotics are administered.
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
1. Candidate for laparoscopic cholecystectomy
2. No infectious disease including acute cholecystitis
3. No severe disease such as diabetes mellitus requiring insulin, renal failure with hemodialysis, etc.
4. No antibiotic administration within a week before operation
5. Provided written informed consent
Key exclusion criteria
1. Switch to open surgery
2. Emergency surgery
3. Allergy to antibiotics
4. Obstructive jaundice
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Matsui |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
2-3-1 Shinmachi Hirakata Osaka
TEL
0728040101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Matsui |
Organization
Kansai Medical University
Division name
Department of Surgery
Zip code
Address
2-3-1 Shinmachi Hirakata Osaka
TEL
0728040101
Homepage URL
matsui@hirakata.kmu.ac.jp
Sponsor or person
Institute
Department of Surgery
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery
Kansai Medical University
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
関西医科大学附属枚方病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 14 | Day |
Last modified on
| 2014 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004528
| Research Plan | |
|---|---|
| Registered date | File name |
| 2014/03/07 | Protocol.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2014/03/07 | UMIN.xlsx |
