Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 1:27 PM
Study NCT ID:
NCT01179750
Status:
UNKNOWN
Last Update Posted:
2010-12-16
First Post:
2010-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-08-29', 'releaseDate': '2011-07-31'}, {'resetDate': '2012-07-09', 'releaseDate': '2012-06-07'}, {'resetDate': '2021-04-08', 'releaseDate': '2021-03-16'}], 'estimatedResultsFirstSubmitDate': '2011-07-31'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 256}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-14', 'studyFirstSubmitDate': '2010-07-27', 'studyFirstSubmitQcDate': '2010-08-10', 'lastUpdatePostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operation time', 'timeFrame': '2 weeks later after operation', 'description': 'operation time: a time from the opening of peritoneal cavity to the retrieval of specimen'}, {'measure': 'amount of blood loss', 'timeFrame': '2 weeks later after operation', 'description': 'amount of blood loss: an amount of blood loss during operation time'}], 'secondaryOutcomes': [{'measure': 'C-reactive protein', 'timeFrame': 'post operative day #0, #1, #5'}, {'measure': 'total lymphocyte count', 'timeFrame': 'post operative day #0, #1, #5'}, {'measure': 'postoperative complications', 'timeFrame': '4 weeks later after operation'}, {'measure': 'drainage from peritoneal cavity during hospital', 'timeFrame': '2 weeks later after operation', 'description': 'amount of drainage: an amount of postoperative draining fluid from peritoneal cavity during hsopital'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ultrasonic coagulating shears in gastrectomy'], 'conditions': ['Stomach Cancer', 'Gastrectomy', 'Ultrasonic Coagulating Shears']}, 'referencesModule': {'references': [{'pmid': '11865342', 'type': 'BACKGROUND', 'citation': 'Tsimoyiannis EC, Jabarin M, Tsimoyiannis JC, Betzios JP, Tsilikatis C, Glantzounis G. Ultrasonically activated shears in extended lymphadenectomy for gastric cancer. World J Surg. 2002 Feb;26(2):158-61. doi: 10.1007/s00268-001-0199-9. Epub 2001 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'Ultrasonic coagulating shears are made for performing for cutting and hemostasis at once during operation. It was proved that a laparoscopic gastric resection showed significantly shorter operative time and less work load distribution, and more stability of bleeding than before an introduction of ultrasonic coagulating shears .\n\nIn an open gastric cancer surgery, ultrasonic coagulating shears have been often used for lymph node dissection or cutting of small vessels in some hospitals in Korea. However its usefulness or effectiveness has not been fully proved. There was only one report about using ultrasonic coagulating shears in open gastrectomy. The report contained small number of subjects and surgical procedures were different from the investigators.\n\nThe investigators expect to reduce operative time and blood loss with ultrasonic coagulating shears. Ultrasonic coagulating shears will also enable us to dissect lymph node with closure of lymphatics. This may reduce the amount of drainage fluid from peritoneal cavity and shorten the removal time of a drain, which will also shorten the hospital stay.\n\nThe objective of this study is to evaluate the safety and benefit of ultrasonic coagulating shears in open gastrectomy including usefulness and effectiveness by a randomized controlled, prospective study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with the diagnosis of gastric cancer\n* The patient who agrees to participate in this study by signing the informed consent form\n\nExclusion Criteria:\n\n* The patient who refuse to participate in this study\n* Have simultaneously other cancer\n* Underwent cancer therapy at past time\n* Have bleeding disorder, coagulation disorder, chronic disease (e.g.heart failure, cardiovascular disease, active hepatitis)\n* Have a previous upper gastrointestinal surgery'}, 'identificationModule': {'nctId': 'NCT01179750', 'briefTitle': 'The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery', 'orgStudyIdInfo': {'id': '2009-08-089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No Ultrasonic Coagulating Shears group', 'description': 'the one arm: operated group without using Ultrasonic coagulation shears during gastrectomy;'}, {'type': 'EXPERIMENTAL', 'label': 'ultrasonic coagulation shears group', 'description': 'the other arm: operated group using ultrasonic coagulation shears during gastrectomy', 'interventionNames': ['Device: Ultrasonic Coagulating Shears']}], 'interventions': [{'name': 'Ultrasonic Coagulating Shears', 'type': 'DEVICE', 'otherNames': ['Harmonic Ace'], 'description': 'comparison of operated groups between with Ultrasonic Coagulating Shears and without them.', 'armGroupLabels': ['ultrasonic coagulation shears group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'JaeMoon Bae, MD.,Ph.D.', 'role': 'CONTACT', 'email': 'jmoon.bae@samsung.com', 'phone': '82-2-3410-0252'}, {'name': 'SeungJong Oh, MD', 'role': 'CONTACT', 'email': 'seungjong.oh@samsung.com', 'phone': '82-2-3410-1735'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jae Moon Bae, Professor', 'role': 'CONTACT', 'email': 'jmoon.bae@samsung.com', 'phone': '+82-2-3410-0252'}], 'overallOfficials': [{'name': 'Jae Moon Bae, MD., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center, Sungkyunkwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jae Moon Bae', 'oldOrganization': 'Samsung Medical Center, Sungkyunkwan University School of Medicine'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-07-31', 'type': 'RELEASE'}, {'date': '2011-08-29', 'type': 'RESET'}, {'date': '2012-06-07', 'type': 'RELEASE'}, {'date': '2012-07-09', 'type': 'RESET'}, {'date': '2021-03-16', 'type': 'RELEASE'}, {'date': '2021-04-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jae Moon Bae, professor, Samsung Medical Center'}}}}