UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000069 |
|---|---|
| Receipt number | R000000115 |
| Scientific Title | Randomized multicentre trial of antibiotic prophylaxis in elective colorectal surgery: Single dose of cefmetazole vs. three doses of cefmetazole |
| Date of disclosure of the study information | 2005/08/19 |
| Last modified on | 2007/07/17 10:06:13 |
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Basic information
Public title
Randomized multicentre trial of antibiotic prophylaxis in elective colorectal surgery: Single dose of cefmetazole vs. three doses of cefmetazole
Acronym
Randomized multicentre trial of antibiotic prophylaxis in elective colorectal surgery: Single dose of cefmetazole vs. three doses of cefmetazole
Scientific Title
Randomized multicentre trial of antibiotic prophylaxis in elective colorectal surgery: Single dose of cefmetazole vs. three doses of cefmetazole
Scientific Title:Acronym
Randomized multicentre trial of antibiotic prophylaxis in elective colorectal surgery: Single dose of cefmetazole vs. three doses of cefmetazole
Region
| Japan |
Condition
Condition
Colorectal diseases in which elective colorectal resection is necessary
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine optimal prophylactic antibiotics administration method in elective colorectal surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of incisional surgical site infection (SSI)
Key secondary outcomes
Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay
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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Single intravenous dose of 1 g cefmetazole just before skin incision,
Interventions/Control_2
Three-dose group given an intravenous dose of 1 g cefmetazole just before skin incision, and two postoperative 1-g doses at 8 and 16 h after the first administration.
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
Colorectal diseases (cancer, large polyp, cacinoid, lymphoma,sarcoma and so on) in which elective colorectal resection is necessary
Key exclusion criteria
1) Age < 20, 80 < Age
2) Emergent operation
3) Ileus
4) No resection
5) Preoperative infectious diseases
6) Penicillin or cephalosporin allergy
7) Antibiotics administration before surgery
8) Inflammatory bowel diseases
9) Angina or myocardial infarction
10) Renal dysfunction
11) Diabetes mellitus
12) Steroid administration before surgery
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Fujita |
Organization
National Cancer Center Hospital
Division name
Colorectal Surgery Division
Zip code
Address
1-1, Tsukiji 5-chome, Chuo-ku, Tokyo
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin Fujita |
Organization
National Cancer Center Hospital
Division name
Colorectal Surgery Division
Zip code
Address
1-1, Tsukiji 5-chome, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
sfujita@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Cancer reseach promotion fund
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2005 | Year | 08 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://archsurg.ama-assn.org/cgi/content/short/142/7/657
Number of participants that the trial has enrolled
Results
A total of 384 patients were enrolled. Seven patients were excluded because of additional surgery or inability to tolerate mechanical preparation. The incidence of incisional SSI was higher in the single-dose group (27/190, 14%) than in the three-dose group (8/119, 4%) (p = 0.009). Incidences of organ/space SSI and other postoperative infectious diseases did not differ significantly between the two groups. In multivariate analysis, antibiotic dose was the only significant factor related to the incidence of incisional SSI.
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
| 2003 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2005 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2005 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2005 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2005 | Year | 12 | Month | 01 | Day |
Other
Other related information
Published in Archives of Surgery
Arch Surg. 2007;142(7):657-661
Management information
Registered date
| 2005 | Year | 08 | Month | 19 | Day |
Last modified on
| 2007 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000115
