Clinical Trials Directory

Trials / Unknown

UnknownNCT03585166

Nursing Fro Laparoscopic vs. Open Hepatectomy

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

Status
Unknown
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURElpaparoscopic hepatectomylaparoscopic hepatectomy: laparoscopic hepatectomy for hepatocellular carcinoma.
PROCEDUREopen hepatectomyopen hepatectomy: open hepatectomy for hepatocellular carcinoma

Timeline

Start date
2017-10-01
Primary completion
2023-10-31
Completion
2023-10-31
First posted
2018-07-12
Last updated
2018-07-12

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03585166. Inclusion in this directory is not an endorsement.