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Nursing Fro Laparoscopic vs. Open Hepatectomy

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ClinicalTrials.gov Identifier: NCT03585166
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Zeng Li, Wuhan Union Hospital, China

Brief 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.

Condition or disease Intervention/treatment
Liver Cancer Liver Neoplasms 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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Efficacy and Nursing Between Laparoscopic Hepatectomy and Open Hepatectomy for Primary Liver Cancer
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

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




Primary Outcome Measures :
  1. The incidence of complications of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,The questionnaire survey [ Time Frame: 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

  2. The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit [ Time Frame: 1 month after discharge ]
    Survival rate, percent

  3. The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit [ Time Frame: 3 month after discharge ]
    Survival rate, percent

  4. The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit [ Time Frame: 6 month after discharge ]
    Survival rate, percent

  5. The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit [ Time Frame: 1 year after discharge ]
    Survival rate, percent

  6. The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit [ Time Frame: 2 year after discharge ]
    Death and recurrence

  7. The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit [ Time Frame: 3 year after discharge ]
    Death and recurrence

  8. The survival rate of primary liver cancer treated by laparoscopic hepatectomy and laparoscopic hepatectomy,Telephone pays a return visit [ Time Frame: 5 year after discharge ]
    Survival rate, percent


Secondary Outcome Measures :
  1. Comparison of oxygen uptake days between laparoscopic hepatectomy and laparoscopic hepatectomy for primary liver cancer, unit: day [ Time Frame: Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year. ]
    Oxygen uptake days, per day

  2. Comparison of ecg monitoring days between laparoscopic hepatectomy and laparoscopic hepatectomy for primary liver cancer Unit: day [ Time Frame: Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year. ]
    Guardianship days, unit: days

  3. Comparison of the number of replacement drainage bags for primary hepatocellular carcinoma between laparoscopic hepatectomy and laparoscopic hepatectomy, unit: number [ Time Frame: Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year. ]
    Compare the number of times to replace the drainage bag, unit: number

  4. Comparison of infusion days between laparoscopic hepatectomy and laparoscopic hepatectomy for primary liver cancer Unit: day [ Time Frame: Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year. ]
    Infusion days, unit: days

  5. Comparison of muscle injection times between laparoscopic hepatectomy and laparoscopic hepatectomy in primary liver cancer: times [ Time Frame: Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year. ]
    Muscle injections,Unit: times

  6. Comparison between laparoscopic hepatectomy and laparoscopic hepatectomy in primary hepatocellular carcinoma Unit: times [ Time Frame: Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year. ]
    Number of subcutaneous injections Unit: times



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult, aged (18- N/A),male/femal,diagnosised with primary hepatoma, received surgical intervention(laparoscopic and open)
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585166


Contacts
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Contact: Zeng Li +86 15327374420 zengli2017@hust.edc.cn
Contact: Ye Lin +86 13437145094

Locations
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China, Hubei
Union hospital Recruiting
Wuhan, Hubei, China, 403322
Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
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Principal Investigator: Li Zeng Department of Hepatobiliary,Union Hospital,Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China

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Responsible Party: Zeng Li, Charge nurse, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT03585166     History of Changes
Other Study ID Numbers: WHUH2018S002
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zeng Li, Wuhan Union Hospital, China:
Liver Cancer
laparoscopic hepatectomy
open hepatectomy

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases