UMIN-CTR Clinical Trial

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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