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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Colorectal diseases in which elective colorectal resection is necessary | |
Classification by specialty |
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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 |
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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. | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 500 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | National Cancer Center Hospital |
Institute | |
Department |
Funding Source | |
Organization | Cancer reseach promotion fund |
Organization | |
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Category of Funding Organization | |
Nationality of Funding Organization | Japan |
Other related organizations | |
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IRB Contact (For public release) | |
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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 |
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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 | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Date analysis concluded |
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Other | |
Other related information | Published in Archives of Surgery
Arch Surg. 2007;142(7):657-661 |
Management information | |||||||
Registered date |
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Last modified on |
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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 |