UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000631 |
|---|---|
| Receipt number | R000000765 |
| Scientific Title | Multicenter phase III study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer (OGSG 0501) |
| Date of disclosure of the study information | 2007/04/01 |
| Last modified on | 2021/11/15 22:19:20 |
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Basic information
Public title
Multicenter phase III study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer (OGSG 0501)
Acronym
OGSG-0501
Scientific Title
Multicenter phase III study of antimicrobial prophylaxis in low-risk patients undergoing distal gastrectomy for gastric cancer (OGSG 0501)
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
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
imamurahiroshisakai@yahoo.co.jp
Sponsor or person
Institute
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department
Personal name
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
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
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(11)70370-X/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(11)70370-X/fulltext
Number of participants that the trial has enrolled
355
Results
Eight patients (5%, 95% CI 2-9%) had surgical-site infections in the intraoperative group compared with 16 (9%, 5-14) in the extended group. The relative risk of surgical-site infections with intraoperative antimicrobial prophylaxis was 0.51 (0.22-1.16), which revealed statistically significant non-inferiority (p<0.0001).
Results date posted
| 2021 | Year | 11 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2012 | Year | 01 | Month | 31 | Day |
Baseline Characteristics
Patients with gastric cancer that was potentially curable with a distal gastrectomy
Participant flow
Between June 2, 2005, and Dec 6, 2007, 355 patients were randomly assigned to receive either intraoperative antimicrobial prophylaxis alone (n=176) or extended antimicrobial prophylaxis (n=179).
Adverse events
.
Outcome measures
The primary endpoint was the incidence of surgical-site infections.
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
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000765
