Colorectal SurgeryPhase 3NCT00292708
Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery
A Phase 3 study testing Cefmetazole (drug) in people with Colorectal Surgery, run by National Cancer Center, Japan at 7 sites in Japan.
Trial summary
To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Cefmetazole (drug)
- How many people
- 500 participants
- Where
- 7 sitesJapan
- Study dates
- May 2004to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on)
- Elective colorectal resection
Who cannot join
- Emergent operation
- Ileus
- No resection
- Preoperative infectious diseases
- Penicillin or cephalosporin allergy
- Antibiotics administration before surgery
Show all 11Show fewer
- Inflammatory bowel diseases
- Angina or myocardial infarction
- Renal dysfunction
- Diabetes mellitus
- Steroid administration before surgery
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Ishikawa Prefectural Central Hospital
Kanazawa
National Cancer Center East Hospital
Kashiwa
Nagoya Medical Center
Nagoya
Niigata Cancer Center Hospital
Niigata
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka
National Cancer Center Hospital
Tokyo
Yamagata Prefectural Central Hospital
Yamagata
About this study
Official title: Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin
To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery
Read the detailed description
Use of prophylactic antibiotics in elective colorectal surgery is essential. Although single-dose prophylactic antibiotics are recommended, the efficacy of single-dose cephalosporin without metronidazole and oral antibiotics is not fully proven. We conducted a multicenter randomized trial of single-dose vs. three doses of the second-generation cephalosporin, cefmetazole.
- Conditions
- Colorectal Surgery
- Being tested
- Cefmetazole (drug)
- Keywords
- Antibiotics, Prophylaxis, Surgical wound infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefmetazole (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of incisional surgical site infection (SSI)
Secondary outcomes (1)
Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startMay 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Japan
- Sponsor type
- Other government
- Investigators
- Shin Fujita, MD. PhD., Principal investigator, Japan National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292708
- Sponsor's protocol ID
- C000000069
- Status last verified
- Feb 2006
- First submitted
- 15 Feb 2006
- Last updated
- 16 Feb 2006
- Results posted
- No
Publications
Fujita S, Saito N, Yamada T, Takii Y, Kondo K, Ohue M, Ikeda E, Moriya Y. Randomized, multicenter trial of antibiotic prophylaxis in elective colorectal surgery: single dose vs 3 doses of a second-generation cephalosporin without metronidazole and oral antibiotics. Arch Surg. 2007 Jul;142(7):657-61. doi: 10.1001/archsurg.142.7.657.
PubMed 17638804
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery: Single-Dose Vs. Three Doses of Second-Generation Cephalosporin
- ClinicalTrials.gov ID
- NCT00292708
- Acronym / sponsor ID
- C000000069
- Conditions
- Colorectal Surgery
- Keywords
- Antibiotics, Prophylaxis, Surgical wound infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- National Cancer Center, JapanOther government
- Study start
- May 2004
- Study completion
- Jul 2005
- First posted
- 16 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery
Detailed description
Use of prophylactic antibiotics in elective colorectal surgery is essential. Although single-dose prophylactic antibiotics are recommended, the efficacy of single-dose cephalosporin without metronidazole and oral antibiotics is not fully proven. We conducted a multicenter randomized trial of single-dose vs. three doses of the second-generation cephalosporin, cefmetazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on)
- Elective colorectal resection
Key exclusion criteria (11 listed)
- Emergent operation
- Ileus
- No resection
- Preoperative infectious diseases
- Penicillin or cephalosporin allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefmetazole (drug) | Drug | – |
Primary outcome
Incidence of incisional surgical site infection (SSI)
1 secondary outcome
Incidences of organ/space SSI and other infectious diseases. Other postoperative complications and postoperative hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2006.
- Derived from this study: PubMed 17638804Fujita S, Saito N, Yamada T, Takii Y, Kondo K, Ohue M, Ikeda E, Moriya Y. Randomized, multicenter trial of antibiotic prophylaxis in elective colorectal surgery: single dose vs 3 doses of a second-generation cephalosporin without metronidazole and oral antibiotics. Arch Surg. 2007 Jul;142(7):657-61. doi: 10.1001/archsurg.142.7.657.
- UMIN Clinical Trial Registry: Unique trial number C000000069Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shin Fujita, MD. PhD. principal investigator
Japan National Cancer Center Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cefmetazole (drug) in people with Colorectal Surgery, run by National Cancer Center, Japan at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of incisional surgical site infection (SSI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00292708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2006.