Colorectal SurgeryPhase 2NCT01220661
Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
A Phase 2 study testing Cefotetan in people with Colorectal Surgery, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses. It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Cefotetan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Dec 2011
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have laparoscopic colorectal surgery for cancer at National Cancer Center
- Patients should sign a written informed consent
- Age between 18-80 years
- Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
- Adequate kidney function Creatinine ≤ 1.5 mg/dl
- No remarkable evidence of heart dysfunction and lung dysfunction
Who cannot join
- Patients undergo emergency surgery with multiple symptoms
- Open colorectal surgery for cancer or conversion to an open procedure
- Patients who undergo only ostomy surgery
- Palliative surgery
- Surgery combined with other organs
- Patients on treatment with recurred cancer
Show all 15Show fewer
- Patients who have active bacterial infection and required parenteral antibiotics
- Patients have an allergy to Cefoxitin
- Other organ cancer history(except who had radical excision for skin cancer)
- Presence of other serious disease
- Mentally ill patients
- Legally unable to participate in clinical trial
- Lactating or pregnant women
- Patients who will obviously fail to regular follow-up visit or will be off study voluntarily
- Not eligible to participate for other reasons by doctor's decision
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center Hospital
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: Phase 2 Study of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses.
It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough.
The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.
Read the detailed description
In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses.
One randomized controlled study reported that surgical site infection rates of three doses prophylactic antibiotics are lower than those of one dose in colorectal surgery (4.3 versus 14.2%). But, surgical site infection rates between one dose and three doses were not different in laparoscopic subgroup of this study (11 versus 11%)
It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough.
The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.
- Conditions
- Colorectal Surgery
- Being tested
- Cefotetan
- Keywords
- Colorectal Surgery, Surgical Wound Infection, Laparoscopy, Anti-Bacterial Agents
- 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.
CefotetanDrug
Also called Yamatetan
preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)
| Study group | Role | What they receive |
|---|---|---|
| One dose | Experimental | One dose prophylactic antibiotic Receives: Drug: Cefotetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
any surgical infections (superficial incisional infection or infection of deep incision space or organ space infection)
Measured: Three weeks after surgery
Secondary outcomes (1)
Overall infection
Overall infection including surgical site infection, pneumonia, urinary tract infection etc.
Measured: Three weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startOct 2010
- 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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ji Won Park, National Cancer Center, Korea
- Investigators
- Jae Hwan Oh, Principal investigator, Center for Colorectal Cancer, National Cancer Center Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220661
- Sponsor's protocol ID
- NCCCTS-10-485
- Status last verified
- Dec 2011
- First submitted
- 12 Oct 2010
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01220661
- Acronym / sponsor ID
- NCCCTS-10-485
- Conditions
- Colorectal Surgery
- Keywords
- Colorectal Surgery, Surgical Wound Infection, Laparoscopy, Anti-Bacterial Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Oct 2010 (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.
In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses.
It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough.
The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.
Detailed description
In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses.
One randomized controlled study reported that surgical site infection rates of three doses prophylactic antibiotics are lower than those of one dose in colorectal surgery (4.3 versus 14.2%). But, surgical site infection rates between one dose and three doses were not different in laparoscopic subgroup of this study (11 versus 11%)
It has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. However, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough.
The investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One dose | Experimental | Drug: CefotetanOne dose prophylactic antibiotic |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients have laparoscopic colorectal surgery for cancer at National Cancer Center
- Patients should sign a written informed consent
- Age between 18-80 years
- Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
- Adequate kidney function Creatinine ≤ 1.5 mg/dl
Key exclusion criteria (15 listed)
- Patients undergo emergency surgery with multiple symptoms
- Open colorectal surgery for cancer or conversion to an open procedure
- Patients who undergo only ostomy surgery
- Palliative surgery
- Surgery combined with other organs
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 |
|---|---|---|
| CefotetanAlso: Yamatetanpreoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision) | Drug | One dose |
Primary outcome
Surgical site infection
Time frame: Three weeks after surgery
any surgical infections (superficial incisional infection or infection of deep incision space or organ space infection)
1 secondary outcome
Overall infection
Time frame: Three weeks 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 13 Dec 2011.
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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.
Jae Hwan Oh principal investigator
Center for Colorectal Cancer, National Cancer Center Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cefotetan in people with Colorectal Surgery, run by National Cancer Center, Korea at 1 site in South Korea.
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 6 inclusion and 15 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 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Surgical site infection (time frame: Three weeks 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 13 Dec 2011.