Open Versus Laparoscopic Left Hepatic Sectionectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial of Open Versus Laparoscopic Left Hepatic Sectionectomy in Treatment of Hepatolithiasis Within an Enhanced Recovery After Surgery Programme

Conditions
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Hepatolithiasis, Laparoscopic Liver Resection, Open Liver Resection, Enhanced Recovery

Intervention / Treatment
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* Procedure: laparoscopic hepatic sectionectomy
* Procedure: open left hepatic sectionectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: open left hepatic sectionectomy<br>patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme | Procedure: open left hepatic sectionectomy<br>* patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme<br>|
| Experimental: laparoscopic hepatic sectionectomy<br>patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme | Procedure: laparoscopic hepatic sectionectomy<br>* patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme<br>* Other names: open left hepatic sectionectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital duration after operation (days) | the length of hospital stay | up to 30 days after liver resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission percentage | Readmission percentage during one year follow-up | up to 30 days after liver resection | 
| Total morbidity | According to The Clavien-Dindo Classification, https://www.assessurgery.com/clavien-dindo-classification/ | up to 1 year after liver resection | 
| Composite endpoint of liver surgery specific morbidity | 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. | up to 1 year after liver resection | 
| Hospital and societal costs | 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. | up to 1 year after liver resection | 
| Incidence of incisional hernias | 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. | up to 1 year after liver resection | 
| Change of serum glutamic oxalacetic transaminase | Change of serum glutamic oxalacetic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7. | up to 7 days after liver resection | 
| Change of serum glutamic-pyruvic transaminase | Change of serum glutamic-pyruvic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7. | up to 7 days after liver resection | 
| Mortality rates | the rate of postoperative death | up to 30 days after liver resection | 
| Operation time(min) | the during of operation | intraoperative | 
| Blood loss(ml) | the volume of blood loss | up to 30 days after liver resection | 
| Blood transfusion (times and units) | intraoperative blood transfusion | intraoperative | 
| C-reactive protein (mg/mL) | C-reactive protein levels on preoperative and postoperative day-1,3,5 | up to 5 days after liver resection |