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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000069
Receipt No. 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

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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
Email

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
Email sfujita@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000115

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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