UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000631
Receipt No. R000000765
Scientific Title Multicenter phase III study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer
Date of disclosure of the study information 2007/04/01
Last modified on 2017/02/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multicenter phase III study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer
Acronym OGSG-0501
Scientific Title Multicenter phase III study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer
Scientific Title:Acronym OGSG-0501
Region
Japan

Condition
Condition distal gastrectomy for gastric cancer
Classification by specialty
Infectious disease Gastrointestinal surgery Operative medicine
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We examine whether AMP before and during surgical operation has the same effect as AMP administered for 3 to 4 days, postoperatively, by a phase III study on SSI.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Incidence of SSI
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A: AMP is administered before and during surgical operation and SSI is detected after surgery.
Interventions/Control_2 Group B: AMP is administered before, during and after surgical operation and SSI is detected after surgery.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.age not limmited.
2.histologically proven gastric cancer
3.ASA score of 1 or 2
4.completion of written informed consent
5.distal gastrectomy with D2 lymphadenectomy and clean-contaminated operation
Key exclusion criteria 1.with some active or uncontrolled infection
2.neoadjuvant chemotherapy
3.PS>3 in ASA
4.administration of steroids
5.decision of ineligible patients by the researcher

Target sample size 342

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Imamura
Organization Toyonaka City Hospital
Division name Dpt.Surgery
Zip code
Address 4-14-1, shibaharacho, Toyonka City, Osaka, Japan, 560-8565
TEL 06-6843-0101
Email imamurahiroshisakai@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Imamura
Organization Toyonaka City Hospital
Division name Dpt.Surgery
Zip code
Address 4-14-1, shibaharacho, Toyonka City, Osaka, Japan, 560-8565
TEL 06-6843-0101
Homepage URL
Email imamurahiroshisakai@yahoo.co.jp

Sponsor
Institute Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Osaka Clinical Study Supporting Organization
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
2007 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(11)70370-X/abstract
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
2005 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2005 Year 03 Month 01 Day
Last follow-up date
2008 Year 08 Month 01 Day
Date of closure to data entry
2009 Year 02 Month 01 Day
Date trial data considered complete
2009 Year 02 Month 01 Day
Date analysis concluded
2009 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 03 Month 07 Day
Last modified on
2017 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000765

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.