Clinical trial NCT03585166: Nursing Fro Laparoscopic vs. Open Hepatectomy
Official title: Comparison of Efficacy and Nursing Between Laparoscopic Hepatectomy and Open Hepatectomy for Primary Liver Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cancer
Liver Neoplasms
Keywords: Liver Cancer
laparoscopic hepatectomy
open hepatectomy
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult, aged (18- N/A),male/femal,diagnosised with primary hepatoma, received surgical intervention(laparoscopic and open)

Brief summary: 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.

Detailed description: Research design and methods:

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.

Statistical 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.

Eligibility criteria: Inclusion criteria:

Hepatocellular 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.

Primary outcomes:
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.
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
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
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
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
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
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
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
Secondary outcomes:
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.
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.
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.
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.
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.
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.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union hospital
state: Hubei
Study officials:
affiliation: Department of Hepatobiliary,Union Hospital,Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China
name: Li Zeng
role: PRINCIPAL_INVESTIGATOR
References: