Nursing Fro Laparoscopic vs. Open Hepatectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Neoplasms; Liver Cancer
• Intervention / Treatment: Procedure: lpaparoscopic hepatectomy; Procedure: open hepatectomy

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Zeng Li; Phone Number: +86 15327374420; Email: zengli2017@hust.edc.cn
• Study Contact Backup: Name: Ye Lin; Phone Number: +86 13437145094

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 403322
      • Recruiting
      • Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult, aged (18- N/A),male/femal,diagnosised with primary hepatoma, received surgical intervention(laparoscopic and open)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
laparoscopic hepatectomy; laparoscopic hepatectomy for primary liver cancer	Procedure: lpaparoscopic hepatectomy; laparoscopic hepatectomy： laparoscopic hepatectomy for hepatocellular carcinoma.
open hepatectomy; open hepatectomy for primary liver cancer	Procedure: open hepatectomy; open hepatectomy: open hepatectomy for hepatocellular carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: Li Zeng, Department of Hepatobiliary,Union Hospital,Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: June 30, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: June 30, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Liver Cancer; laparoscopic hepatectomy; open hepatectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: WHUH2018S002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No