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

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 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


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

Value
https://center6.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