UMIN-CTR Clinical Trial

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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