Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-27 @ 1:13 AM
Study NCT ID:
NCT03585166
Status:
UNKNOWN
Last Update Posted:
2018-07-12
First Post:
2018-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nursing Fro Laparoscopic vs. Open Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-30', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-06-30', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of complications of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,The questionnaire survey', 'timeFrame': 'Patients with hepatocellular carcinoma who were hospitalized together on October 1, 2017 were studied at the time point before discharge.', 'description': 'The incidence of complications, in percent'}, {'measure': 'The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit', 'timeFrame': '1 month after discharge', 'description': 'Survival rate, percent'}, {'measure': 'The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit', 'timeFrame': '3 month after discharge', 'description': 'Survival rate, percent'}, {'measure': 'The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit', 'timeFrame': '6 month after discharge', 'description': 'Survival rate, percent'}, {'measure': 'The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit', 'timeFrame': '1 year after discharge', 'description': 'Survival rate, percent'}, {'measure': 'The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit', 'timeFrame': '2 year after discharge', 'description': 'Death and recurrence'}, {'measure': 'The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit', 'timeFrame': '3 year after discharge', 'description': 'Death and recurrence'}, {'measure': 'The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit', 'timeFrame': '5 year after discharge', 'description': 'Survival rate, percent'}], 'secondaryOutcomes': [{'measure': 'Comparison of oxygen uptake days between laparoscopic hepatectomy and laparoscopic hepatectomy for primary liver cancer, unit: day', 'timeFrame': 'Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.', 'description': 'Oxygen uptake days, per day'}, {'measure': 'Comparison of ecg monitoring days between laparoscopic hepatectomy and laparoscopic hepatectomy for primary liver cancer Unit: day', 'timeFrame': 'Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.', 'description': 'Guardianship days, unit: days'}, {'measure': 'Comparison of the number of replacement drainage bags for primary hepatocellular carcinoma between laparoscopic hepatectomy and laparoscopic hepatectomy, unit: number', 'timeFrame': 'Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.', 'description': 'Compare the number of times to replace the drainage bag, unit: number'}, {'measure': 'Comparison of infusion days between laparoscopic hepatectomy and laparoscopic hepatectomy for primary liver cancer Unit: day', 'timeFrame': 'Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.', 'description': 'Infusion days, unit: days'}, {'measure': 'Comparison of muscle injection times between laparoscopic hepatectomy and laparoscopic hepatectomy in primary liver cancer: times', 'timeFrame': 'Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.', 'description': 'Muscle injections,Unit: times'}, {'measure': 'Comparison between laparoscopic hepatectomy and laparoscopic hepatectomy in primary hepatocellular carcinoma Unit: times', 'timeFrame': 'Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.', 'description': 'Number of subcutaneous injections Unit: times'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver Cancer', 'laparoscopic hepatectomy', 'open hepatectomy'], 'conditions': ['Liver Cancer', 'Liver Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study was divided into laparoscopic hepatectomy (observation group) and laparoscopic hepatectomy (control group).Compared two groups of age, sex, body mass index (BMI), tumor diameter, number of tumors (single/multiple), pathologic characteristics, HBsAg (positive/negative), liver function, AFP, Child - Pugh, grading, nursing method and comparison of two groups of patients after surgery (surgical incision length, intraoperative blood, intraoperative blood transfusion and transfusion volume, operation time) the number of cases of and postoperative rehabilitation (death cases, for the first time the meal time, anus exhaust time, analgesic bed, first time, the abdominal cavity drainage tube time, length of hospital stay, postoperative days and liver function index.Follow-up: the survival rates of the two groups were compared in six months, one year, two years, three years and five years.In this study, the initial selection of the minimum sample size of 30 cases, plus 20% inefficiencies, the final initial selection of 36 cases, and the later expansion of the sample size of 100 cases.The research date starts on October 1, 2017.', 'detailedDescription': 'Research design and methods:\n\nThis study was divided into laparoscopic hepatectomy (observation group) and laparoscopic hepatectomy (control group).Compared two groups of age, sex, body mass index (BMI), tumor diameter, number of tumors (single/multiple), pathologic characteristics, HBsAg (positive/negative), liver function, AFP, Child - Pugh, grading, nursing method and comparison of two groups of patients after surgery (surgical incision length, intraoperative blood, intraoperative blood transfusion and transfusion volume, operation time) the number of cases of and postoperative rehabilitation (death cases, for the first time the meal time, anus exhaust time, analgesic bed, first time, the abdominal cavity drainage tube time, length of hospital stay, postoperative days and liver function index.Follow-up: the survival rates of the two groups were compared in six months, one year, two years, three years and five years.In this study, the initial selection of the minimum sample size of 30 cases, plus 20% inefficiencies, the final initial selection of 36 cases, and the later expansion of the sample size of 100 cases.\n\nStatistical methods: by means of SPSS 23.0 to analyze the data, all data after the normal test to choose the appropriate statistical methods, the normal distribution of measurement data in the two groups use surgery and postoperative recovery using two sets of samples t test, liver function index using analysis of variance, non-normal distribution using nonparametric test, count data chi-square test, P \\< 0.05 for the difference was statistically significant.Survival analysis was performed on two groups of patients.The research date starts on October 1, 2017.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult, aged (18- N/A),male/femal,diagnosised with primary hepatoma, received surgical intervention(laparoscopic and open)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nHepatocellular carcinoma There was no distant metastasis in patients with malignant tumors. Exclusion criteria: primary tumor diameter \\> 10cm Thrombosis of portal or inferior vena cava carcinoma Severe organic disease or cirrhosis of the liver Laparoscopic transposition of the abdomen Concomitant coagulant function abnormal patient.'}, 'identificationModule': {'nctId': 'NCT03585166', 'briefTitle': 'Nursing Fro Laparoscopic vs. Open Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Comparison of Efficacy and Nursing Between Laparoscopic Hepatectomy and Open Hepatectomy for Primary Liver Cancer', 'orgStudyIdInfo': {'id': 'WHUH2018S002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'laparoscopic hepatectomy', 'description': 'laparoscopic hepatectomy for primary liver cancer', 'interventionNames': ['Procedure: lpaparoscopic hepatectomy']}, {'label': 'open hepatectomy', 'description': 'open hepatectomy for primary liver cancer', 'interventionNames': ['Procedure: open hepatectomy']}], 'interventions': [{'name': 'lpaparoscopic hepatectomy', 'type': 'PROCEDURE', 'description': 'laparoscopic hepatectomy： laparoscopic hepatectomy for hepatocellular carcinoma.', 'armGroupLabels': ['laparoscopic hepatectomy']}, {'name': 'open hepatectomy', 'type': 'PROCEDURE', 'description': 'open hepatectomy: open hepatectomy for hepatocellular carcinoma', 'armGroupLabels': ['open hepatectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '403322', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Union hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Zeng Li', 'role': 'CONTACT', 'email': 'zengli2017@hust.edc.cn', 'phone': '+86 15327374420'}, {'name': 'Ye Lin', 'role': 'CONTACT', 'phone': '+86 13437145094'}], 'overallOfficials': [{'name': 'Li Zeng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Hepatobiliary,Union Hospital,Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Charge nurse', 'investigatorFullName': 'Zeng Li', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}