Nursing Fro Laparoscopic vs. Open Hepatectomy

NCT03585166 | Unknown

• 1 other identifier: WHUH2018S002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Liver Neoplasms

Keywords

Liver Cancer; laparoscopic hepatectomy; open hepatectomy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Comparison of oxygen uptake days between laparoscopic hepatectomy and laparoscopic hepatectomy for primary liver cancer, unit: 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

  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

  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

  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

  Patients with liver cancer who are hospitalized on 1 October 2017 will be included in the study date.The study time is 1 year.

Study Arms (2)

laparoscopic hepatectomy

laparoscopic hepatectomy for primary liver cancer

Procedure: lpaparoscopic hepatectomy

open hepatectomy

open hepatectomy for primary liver cancer

Procedure: open hepatectomy

Interventions

lpaparoscopic hepatectomy PROCEDURE

laparoscopic hepatectomy： laparoscopic hepatectomy for hepatocellular carcinoma.

laparoscopic hepatectomy

open hepatectomy PROCEDURE

open hepatectomy: open hepatectomy for hepatocellular carcinoma

open hepatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

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

Study Sites (1)

Union hospital

Wuhan, Hubei, 403322, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Li Zeng

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeng Li

CONTACT

+86 15327374420; zengli2017@hust.edc.cn

Ye Lin

CONTACT

+86 13437145094

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Charge nurse

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: July 12, 2018
• Study Start: October 1, 2017
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: July 12, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)