Colorectal NeoplasmsPhase 3NCT00508690
Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
A Phase 3 study testing cefmetazole and kanamycin/metronidazole in people with Colorectal Neoplasms, run by Japan Multinational Trial Organization at 5 sites in Japan.
Trial summary
The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- cefmetazole and kanamycin/metronidazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 5 sitesJapan
- Study dates
- Sep 2007to Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection
Who cannot join
- ECOG Performance Status >=2
- Age<20
- Any organ dysfunction
- Ileus
- Preoperative infectious disease
- Antibiotic administration before surgery
Show all 11Show fewer
- Steroid administration before surgery
- Neo-adjuvant radiation and/or chemo therapy
- Severe diabetes mellitus
- Pregnancy/lactational woman
- Severe allergy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Kyoto Univercity Hospital
Kyoto, Kyoto, 606-8507
National Hospital Organization, Kyoto Medical Center
Kyoto, Kyoto, 612-8555
Kyoto Katsura Hospital
Kyoto, Kyoto, 6158256
Kitano Hospital
Osaka, Osaka, 5308480
Tenriyorozu Hospital
Tenri, Nara, 6328552
About this study
Official title: Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.
Read the detailed description
The use of antibiotic prophylaxis in patients who undergo elective colorectal surgery is now accepted universally. But the rout of administration should be systematic, oral, or both is controversial. Furthermore, although many trails have been performed, no trial limited to laparoscopic surgery is performed. We compare 2 approaches - oral and systemic versus systemic antibiotic prophylaxis - in limited to elective laparoscopic colorectal surgery.
- Conditions
- Colorectal Neoplasms
- Being tested
- cefmetazole, kanamycin/metronidazole
- Keywords
- Antibiotic Prophylaxis, Colorectal Surgery, Laparoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefmetazoleDrug
Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
kanamycin/metronidazoleDrug
2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
| Study group | Role | What they receive |
|---|---|---|
| IV | Active comparator | Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery Receives: Drug: cefmetazole |
| Oral/IV | Active comparator | 2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery Receives: Drug: kanamycin/metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and classification of surgical site infection (SSI)
Measured: Within the first 30 days after surgery
Secondary outcomes (1)
Incidence of colitis, other infectious diseases and other postoperative complications.
Measured: Within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Multinational Trial Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroaki Hata, Japan Multinational Trial Organization
- Investigators
- Hiroaki Hata, MD, Principal investigator, National Hospital Organization Kyoto Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508690
- Sponsor's protocol ID
- JMTO PREV07-01
- Other IDs
- UMIN000000776
- Status last verified
- Sep 2012
- First submitted
- 27 Jul 2007
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
- ClinicalTrials.gov ID
- NCT00508690
- Acronym / sponsor ID
- JMTO PREV07-01
- Conditions
- Colorectal Neoplasms
- Keywords
- Antibiotic Prophylaxis, Colorectal Surgery, Laparoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Japan Multinational Trial OrganizationUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Jul 2007 (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.
The purpose of this study is to determine optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.
Detailed description
The use of antibiotic prophylaxis in patients who undergo elective colorectal surgery is now accepted universally. But the rout of administration should be systematic, oral, or both is controversial. Furthermore, although many trails have been performed, no trial limited to laparoscopic surgery is performed. We compare 2 approaches - oral and systemic versus systemic antibiotic prophylaxis - in limited to elective laparoscopic colorectal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV | Active comparator | Drug: cefmetazoleIntravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery |
| Oral/IV | Active comparator | Drug: kanamycin/metronidazole2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection
Key exclusion criteria (11 listed)
- ECOG Performance Status >=2
- Age<20
- Any organ dysfunction
- Ileus
- Preoperative infectious disease
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 |
|---|---|---|
| cefmetazoleIntravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery | Drug | IV |
| kanamycin/metronidazole2 doses of oral kanamycin(1g)/ metronidazole(750mg) administration on the day before surgery with intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery | Drug | Oral/IV |
Primary outcome
Incidence and classification of surgical site infection (SSI)
Time frame: Within the first 30 days after surgery
1 secondary outcome
Incidence of colitis, other infectious diseases and other postoperative complications.
Time frame: Within the first 30 days after surgery
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 19 Sep 2012.
- UMIN Clinical Trial Registry: Unique trial number UMIN000000776Link 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.
Hiroaki Hata, MD principal investigator
National Hospital Organization Kyoto Medical Center
5 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 and kanamycin/metronidazole in people with Colorectal Neoplasms, run by Japan Multinational Trial Organization at 5 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 1 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 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 and classification of surgical site infection (SSI) (time frame: Within the first 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2012.