Enhanced Recovery, Hepatolithiasis, Laparoscopic Liver Resection, Open Liver Resection
Conditions
Brief summary
Laparoscopic left sectionectomy has been associated with shorter hospital stay and reduced overall morbidity compared with open left sectionectomy. Strong evidence has not, however, been provided.
Detailed description
The application of laparoscopic technology to liver surgery has been developing rapidly, yet very few studies have been conducted to compare the outcomes between open and laparoscopic liver resections. So little is known about their advantages and disadvantages. The aim of this prospective randomized study is to compare the outcomes between laparoscopic and open liver resection in treatment of hepatolithiasis within the left lobes within an enhanced recovery after surgery programme.
Interventions
PROCEDURElaparoscopic hepatic sectionectomy
patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme
PROCEDUREopen left hepatic sectionectomy
patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme
Sponsors
The Second Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients suitable for undergoing both laparoscopic left sectionectomy as well as open left sectionectomy of the liver * Able to understand the nature of the study and what will be required of them * Men and non-pregnant,non-lactating women between age 18-80 * BMI between 18-35 * Patients with ASA I-II-III
Exclusion criteria
* Inability to give written informed consent * Patients undergoing liver resection other than left lateral hepatic sectionectomy * Patients with ASA IV-V Underlying liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital duration after operation (days) | up to 30 days after liver resection | the length of hospital stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total morbidity | up to 1 year after liver resection | According to The Clavien-Dindo Classification, https://www.assessurgery.com/clavien-dindo-classification/ |
| Composite endpoint of liver surgery specific morbidity | up to 1 year after liver resection | Parameter composed of a combination of procedure-specific complications and considered as a single, dichotomous outcome: operative mortality, intra-abdominal haemorrhage, ascites, bile leakage, intra-abdominal abscess and postresectional liver failure. These components, which are all specific to liver surgery and have substantial clinical relevance, reflect Dindo grade 3-5 complications. A composite score of 1 (=failure) will reflect the occurrence of at least one of the above liver specific complications, consequently a score of 0 (=success) will be assigned if none occur. |
| Hospital and societal costs | up to 1 year after liver resection | The economic evaluation will include a cost-utility analysis from a Dutch societal perspective. The incremental costs per Quality Adjusted Life Year (QALY) gained will be based on utility scores from the EQ-5D. All hospital expenses (direct and indirect) related to both interventions will be monitored. In addition, a cost questionnaire offered at the regular follow-up consultation (3, 6 and 12 months) will help us to assess the societal and individual costs outside health care relating to patients' absence, impaired mobility, work or normal daily activities. |
| Incidence of incisional hernias | up to 1 year after liver resection | To assess the incidence of incisional hernias in laparoscopic and open left lateral hepatic sectionectomy patients will be contacted at a mean time of 1 year after resection to receive an ultrasound to diagnose incisional hernia. |
| Change of serum glutamic oxalacetic transaminase | up to 7 days after liver resection | Change of serum glutamic oxalacetic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7. |
| Readmission percentage | up to 30 days after liver resection | Readmission percentage during one year follow-up |
| Mortality rates | up to 30 days after liver resection | the rate of postoperative death |
| Operation time(min) | intraoperative | the during of operation |
| Blood loss(ml) | up to 30 days after liver resection | the volume of blood loss |
| Blood transfusion (times and units) | intraoperative | intraoperative blood transfusion |
| C-reactive protein (mg/mL) | up to 5 days after liver resection | C-reactive protein levels on preoperative and postoperative day-1,3,5 |
| Change of serum glutamic-pyruvic transaminase | up to 7 days after liver resection | Change of serum glutamic-pyruvic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7. |
Countries
China
Contacts
Primary Contacthui s hou, master
Backup Contactshubo s pan, Doctor
Outcome results
None listed