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临床试验/NCT03585166
NCT03585166Unknown不适用

Comparison of Efficacy and Nursing Between Laparoscopic Hepatectomy and Open Hepatectomy for Primary Liver Cancer

Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
The incidence of complications of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,The questionnaire survey

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The incidence of complications of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,The questionnaire survey

时间窗: Patients with hepatocellular carcinoma who were hospitalized together on October 1, 2017 were studied at the time point before discharge.

The incidence of complications, in percent

The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit

时间窗: 5 year after discharge

Survival rate, percent

次要结局

  • Comparison of oxygen uptake days between laparoscopic hepatectomy and laparoscopic hepatectomy for primary liver cancer, unit: day(Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.)
  • Comparison of the number of replacement drainage bags for primary hepatocellular carcinoma between laparoscopic hepatectomy and laparoscopic hepatectomy, unit: number(Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.)
  • Comparison of ecg monitoring days between laparoscopic hepatectomy and laparoscopic hepatectomy for primary liver cancer Unit: day(Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.)
  • Comparison of infusion days between laparoscopic hepatectomy and laparoscopic hepatectomy for primary liver cancer Unit: day(Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.)
  • Comparison of muscle injection times between laparoscopic hepatectomy and laparoscopic hepatectomy in primary liver cancer: times(Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.)
  • Comparison between laparoscopic hepatectomy and laparoscopic hepatectomy in primary hepatocellular carcinoma Unit: times(Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.)

研究者

发起方
Wuhan Union Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeng Li

Charge nurse

Wuhan Union Hospital, China

研究点 (1)

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