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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003749
Receipt No. 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

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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
Email

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
Email matsui@hirakata.kmu.ac.jp

Sponsor
Institute Department of Surgery
Kansai Medical University
Institute
Department

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
Email

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
URL(English) https://upload.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


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