- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00508690
Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
September 18, 2012 updated by: Hiroaki Hata, Japan Multinational Trial Organization
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
584
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kyoto, Japan, 606-8507
- Kyoto Univercity Hospital
-
Kyoto, Japan, 612-8555
- National Hospital Organization, Kyoto Medical Center
-
Kyoto, Japan, 6158256
- Kyoto Katsura Hospital
-
Osaka, Japan, 5308480
- Kitano Hospital
-
-
Nara
-
Tenri, Nara, Japan, 6328552
- Tenriyorozu Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection
Exclusion Criteria:
- ECOG Performance Status >=2
- Age<20
- Any organ dysfunction
- Ileus
- Preoperative infectious disease
- Antibiotic administration before surgery
- Steroid administration before surgery
- Neo-adjuvant radiation and/or chemo therapy
- Severe diabetes mellitus
- Pregnancy/lactational woman
- Severe allergy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: IV
Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
|
Intravenous dose of 1g cefmetazole just before surgery and additional doses every 3hs during surgery
|
ACTIVE_COMPARATOR: Oral/IV
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence and classification of surgical site infection (SSI)
Time Frame: Within the first 30 days after surgery
|
Within the first 30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of colitis, other infectious diseases and other postoperative complications.
Time Frame: Within the first 30 days after surgery
|
Within the first 30 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hiroaki Hata, MD, National Hospital Organization Kyoto Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (ACTUAL)
December 1, 2011
Study Completion (ACTUAL)
December 1, 2011
Study Registration Dates
First Submitted
July 27, 2007
First Submitted That Met QC Criteria
July 27, 2007
First Posted (ESTIMATE)
July 30, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
September 19, 2012
Last Update Submitted That Met QC Criteria
September 18, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Metronidazole
- Kanamycin
- Cefmetazole
Other Study ID Numbers
- JMTO PREV07-01
- UMIN000000776
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Neoplasms
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
NuCana plcCompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States, France, United Kingdom
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Active, not recruitingColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal CancerUnited States
-
Pawel KalinskiNational Cancer Institute (NCI)CompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States
-
The Queen Elizabeth HospitalNovartis; AmgenCompletedColorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalAustralia
-
Novartis PharmaceuticalsCompletedColorectal Cancer | Colorectal Tumors | Colorectal Carcinoma | Neoplasms, ColorectalUnited States
-
Jeremy MeyerUniversity Hospital, Geneva; Hôpital Fribourgeois; Spital Biel, SwitzerlandNot yet recruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenoma | Colorectal Adenocarcinoma | Colorectal Polyp | Colorectal Neoplasms Malignant | Colorectal Neoplasms, Benign
-
ProgenaBiomeRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Cancer Metastatic | Colorectal Carcinoma | Colorectal Adenocarcinoma | Colorectal SarcomaUnited States
-
Bristol-Myers SquibbNovartisActive, not recruitingColorectal Cancer | Colorectal Neoplasm | Colorectal Tumors | Colorectal CarcinomaItaly, United States, Canada, Spain, Argentina, Australia, Belgium, Chile, Czechia, Germany
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Disorders | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Polyp | Colorectal Neoplasms Malignant | Colorectal Adenomatous Polyp | Colorectal Cancer Stage I | Colorectal Adenoma... and other conditionsUnited States, Italy, China, Spain, Japan
Clinical Trials on cefmetazole
-
National Cancer Center, JapanCompleted
-
Peking Union Medical College HospitalRecruitingPostoperative Infection | Antibiotics | LactateChina
-
Julio RamirezUniversity of LouisvilleTerminatedOsteomyelitisUnited States