Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2025-12-28 @ 12:00 PM
Study NCT ID:
NCT01220661
Status:
COMPLETED
Last Update Posted:
2011-12-13
First Post:
2010-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015313', 'term': 'Cefotetan'}], 'ancestors': [{'id': 'D002513', 'term': 'Cephamycins'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-11', 'studyFirstSubmitDate': '2010-10-12', 'studyFirstSubmitQcDate': '2010-10-13', 'lastUpdatePostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical site infection', 'timeFrame': 'Three weeks after surgery', 'description': 'any surgical infections (superficial incisional infection or infection of deep incision space or organ space infection)'}], 'secondaryOutcomes': [{'measure': 'Overall infection', 'timeFrame': 'Three weeks after surgery', 'description': 'Overall infection including surgical site infection, pneumonia, urinary tract infection etc.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colorectal Surgery', 'Surgical Wound Infection', 'Laparoscopy', 'Anti-Bacterial Agents'], 'conditions': ['Colorectal Surgery']}, 'descriptionModule': {'briefSummary': 'In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses.\n\nIt 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.\n\nThe investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.', 'detailedDescription': 'In colorectal surgery, the use of prophylactic antibiotics is recommended. The standard use of antibiotics for colorectal surgery is three doses.\n\nOne 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%)\n\nIt 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.\n\nThe investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients have laparoscopic colorectal surgery for cancer at National Cancer Center\n* Patients should sign a written informed consent\n* Age between 18-80 years\n* Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3\n* Adequate kidney function Creatinine ≤ 1.5 mg/dl\n* No remarkable evidence of heart dysfunction and lung dysfunction\n\nExclusion Criteria:\n\n* Patients undergo emergency surgery with multiple symptoms\n* Open colorectal surgery for cancer or conversion to an open procedure\n* Patients who undergo only ostomy surgery\n* Palliative surgery\n* Surgery combined with other organs\n* Patients on treatment with recurred cancer\n* Patients who have active bacterial infection and required parenteral antibiotics\n* Patients have an allergy to Cefoxitin\n* Other organ cancer history(except who had radical excision for skin cancer)\n* Presence of other serious disease\n* Mentally ill patients\n* Legally unable to participate in clinical trial\n* Lactating or pregnant women\n* Patients who will obviously fail to regular follow-up visit or will be off study voluntarily\n* Not eligible to participate for other reasons by doctor's decision"}, 'identificationModule': {'nctId': 'NCT01220661', 'briefTitle': 'Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': 'Phase 2 Study of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery', 'orgStudyIdInfo': {'id': 'NCCCTS-10-485'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One dose', 'description': 'One dose prophylactic antibiotic', 'interventionNames': ['Drug: Cefotetan']}], 'interventions': [{'name': 'Cefotetan', 'type': 'DRUG', 'otherNames': ['Yamatetan'], 'description': 'preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)', 'armGroupLabels': ['One dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-769', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'overallOfficials': [{'name': 'Jae Hwan Oh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Colorectal Cancer, National Cancer Center Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Ji Won Park', 'investigatorAffiliation': 'National Cancer Center, Korea'}}}}