Nursing Fro Laparoscopic vs. Open Hepatectomy

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03585166
• Other study ID #: WHUH2018S002
• Status: Recruiting
• Start date: October 1, 2017
• Est. completion date: October 31, 2023

Study information

• Verified date: June 2018
• Source: Wuhan Union Hospital, China
• Contact: Zeng Li
• Phone: +86 15327374420
• Email: zengli2017[@]hust.edc.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Procedure:
• lpaparoscopic hepatectomy
laparoscopic hepatectomy: laparoscopic hepatectomy for hepatocellular carcinoma.
• open hepatectomy
open hepatectomy: open hepatectomy for hepatocellular carcinoma

Locations

Country	Name	City	State
China	Union hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of complications of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,The questionnaire survey	The incidence of complications, in percent	Patients with hepatocellular carcinoma who were hospitalized together on October 1, 2017 were studied at the time point before discharge.
Primary	The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit	Survival rate, percent	1 month after discharge
Primary	The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit	Survival rate, percent	3 month after discharge
Primary	The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit	Survival rate, percent	6 month after discharge
Primary	The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit	Survival rate, percent	1 year after discharge
Primary	The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit	Death and recurrence	2 year after discharge
Primary	The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit	Death and recurrence	3 year after discharge
Primary	The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit	Survival rate, percent	5 year after discharge
Secondary	Comparison of oxygen uptake days between laparoscopic hepatectomy and laparoscopic hepatectomy for primary liver cancer, unit: day	Oxygen uptake days, per 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.
Secondary	Comparison of ecg monitoring days between laparoscopic hepatectomy and laparoscopic hepatectomy for primary liver cancer Unit: day	Guardianship days, unit: days	Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.
Secondary	Comparison of the number of replacement drainage bags for primary hepatocellular carcinoma between laparoscopic hepatectomy and laparoscopic hepatectomy, unit: number	Compare the number of times to replace the drainage bag, 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.
Secondary	Comparison of infusion days between laparoscopic hepatectomy and laparoscopic hepatectomy for primary liver cancer Unit: day	Infusion days, unit: days	Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.
Secondary	Comparison of muscle injection times between laparoscopic hepatectomy and laparoscopic hepatectomy in primary liver cancer: times	Muscle injections,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.
Secondary	Comparison between laparoscopic hepatectomy and laparoscopic hepatectomy in primary hepatocellular carcinoma Unit: times	Number of subcutaneous injections 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.