UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000776 |
|---|---|
| Receipt number | R000000935 |
| Scientific Title | Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibiotics |
| Date of disclosure of the study information | 2007/08/01 |
| Last modified on | 2017/08/02 18:35:38 |
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Basic information
Public title
Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibiotics
Acronym
Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibiotics
Scientific Title
Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibiotics
Scientific Title:Acronym
Randomized controlled trial of antibiotic prophylaxis in elective laparoscopic colorectal surgery: Oral and systemic versus systemic antibiotics
Region
| Japan |
Condition
Condition
Colorectal tumor with planned elective laparoscopic resection
Classification by specialty
| Infectious disease | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine optimal prophylactic antibiotic administration method in elective laparoscopic colorectal surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence and classification of surgical site infection (SSI)
Key secondary outcomes
Incidence of colitis, other infectious diseases and other postoperative complications.
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
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
Interventions/Control_2
2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection
Key exclusion criteria
1) ECOG Performance Status >=2
2) Age<20
3) Any organ dysfunction
4) Ileus
5) Preoperative infectious disease
6) Antibiotic administration before surgery
7) Steroid administration before surgery
8) Neo-adjuvant radiation and/or chemo therapy
9) Diabetes mellitus
10) Pregnancy/lactational woman
11) Severe allergy
Target sample size
580
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Hata |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Surgery Division
Zip code
Address
1-1, Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
hhata-kyt@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Hata |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Surgery Division
Zip code
Address
1-1, Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
Homepage URL
hhata@kyotolan.hosp.go.jp
Sponsor or person
Institute
The Japan-Multinational Trial Organization(JMTO)
Institute
Department
Personal name
Funding Source
Organization
None
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
YES
Study ID_1
NCT00508690
Org. issuing International ID_1
ClinicalTrials.gov
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 | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/26756752
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
Main results already published
Date of protocol fixation
| 2007 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 07 | Month | 26 | Day |
Last modified on
| 2017 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000935
