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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001062
Receipt No. R000001289
Scientific Title Randomized clinical trial about the period of antimicrobial prophylaxis administration in total gastrectomy for gastric cancer.
Date of disclosure of the study information 2008/03/03
Last modified on 2013/04/09

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Basic information
Public title Randomized clinical trial about the period of antimicrobial prophylaxis administration in total gastrectomy for gastric cancer.
Acronym RCT of antimicrobial prophylaxis in total gastrectomy.
Scientific Title Randomized clinical trial about the period of antimicrobial prophylaxis administration in total gastrectomy for gastric cancer.
Scientific Title:Acronym RCT of antimicrobial prophylaxis in total gastrectomy.
Region
Japan

Condition
Condition Gastric cancer patients undergoing elective total gastrectomy
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In the U.S., the National Surgical Infection Prevention Project recommends that prophylactic antibiotics not be extended beyond 24 hours of the end of the operation. On the other hands, most Japanese surgeons use antimicrobial prophylaxis until 3 days of postoperativelly. The optimal duration of antimicrobial prophylaxis has been controversial. The Japan Society for Surgical infection is now conducting a randomized trial to investigate the optimal duration of antimicrobial prophylaxis in gastric cancer patients who received with total gastrectomy. This study compared the efficacy of U.S. recommended administration and Japanese common administration for the prevention of surgical site infection in patients undergoing elective total gastrectomy for gastric cancer. The aim of this study is to establish evidence unique in Japan.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome is to show that a 24 hours antibiotic administration of the end of the operation was not inferior to the 3 days antibiotic administration of the postoperative period.
Key secondary outcomes The secondary outcome is to investigate the incidence of remote infection in each group.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ampicillin-sulbactam is administered after the induction of anesthesia, and the patients received an additional dose if the operation was prolonged beyond 3 hour, and Ampicillin-sulbactam was administered again twice daily for 3 consecutive days after the operation
Interventions/Control_2 Ampicillin-sulbactam is administered after the induction of anesthesia, and the patients received an additional dose if the operation was prolonged beyond 3 hour, and Ampicillin-sulbactam was administered at 6 hour and 18hour at end of the operation.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Gastric cancer patients undergoing elective total gastrectomy (up to D2 lymph node resection by Japanese classification and R0 resection by UICC TNM Classification).
Key exclusion criteria Exclusion criteria are as follows.
Receive thoracotomy or other organ resection. Laparoscopic (assisted) surgery.
Cancer of the remnant stomach. Those who received steroid therapy or radiotherapy. Those who were allergic to beta lactumase inhibitor, pregnant, received antibiotic treatment in the past 2 weeks, had an infection at the time of surgery, had malignant disease of other organ.
Those with cardiac dysfunction, liver dysfunction, renal dysfunction, severe diabetes mellitus, or ASA score >3.
Target sample size 460

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinobu Sumiyama
Organization Japan Society for Surgical Infection
Division name The Chief director
Zip code
Address 2-17-6, Ohashi, Meguro-Ku, Tokyo, 153-8515, Japan
TEL 03-3481-7316
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masato Kusunoki
Organization Japan Society for Surgical Infection
Division name Chairman of randomized clinical trial committee
Zip code
Address 2-174, Edobashi, Tsu, Mie, 514-8507, Japan
TEL 059-231-5305
Homepage URL
Email

Sponsor
Institute Randomized clinical trial committee, Japan Society for Surgical Infection
Institute
Department

Funding Source
Organization Japan Society for Surgical Infection
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

Other administrative information
Date of disclosure of the study information
2008 Year 03 Month 03 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 02 Month 28 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2010 Year 05 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 31 Day
Date trial data considered complete
2012 Year 05 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 03 Month 03 Day
Last modified on
2013 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001289

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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