Nursing Fro Laparoscopic vs. Open Hepatectomy

NCT ID: NCT03585166

Last Updated: 2018-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2023-10-31

Brief Summary

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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

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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

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Liver Cancer Liver Neoplasms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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laparoscopic hepatectomy

laparoscopic hepatectomy for primary liver cancer

lpaparoscopic hepatectomy

Intervention Type PROCEDURE

laparoscopic hepatectomy: laparoscopic hepatectomy for hepatocellular carcinoma.

open hepatectomy

open hepatectomy for primary liver cancer

open hepatectomy

Intervention Type PROCEDURE

open hepatectomy: open hepatectomy for hepatocellular carcinoma

Interventions

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lpaparoscopic hepatectomy

laparoscopic hepatectomy: laparoscopic hepatectomy for hepatocellular carcinoma.

Intervention Type PROCEDURE

open hepatectomy

open hepatectomy: open hepatectomy for hepatocellular carcinoma

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Zeng Li

Charge nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Zeng

Role: PRINCIPAL_INVESTIGATOR

Department of Hepatobiliary,Union Hospital,Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China

Locations

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Union hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zeng Li

Role: CONTACT

+86 15327374420

Ye Lin

Role: CONTACT

+86 13437145094

Other Identifiers

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WHUH2018S002

Identifier Type: -

Identifier Source: org_study_id

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