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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
88
patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme
patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme
The second hospital of Anhui Medical University,
Hefei, Anhui, China
RECRUITINGHospital duration after operation (days)
the length of hospital stay
Time frame: up to 30 days after liver resection
Readmission percentage
Readmission percentage during one year follow-up
Time frame: up to 30 days after liver resection
Total morbidity
According to The Clavien-Dindo Classification, https://www.assessurgery.com/clavien-dindo-classification/
Time frame: 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.
Time frame: 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.
Time frame: up to 1 year after liver resection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: up to 7 days after liver resection
Mortality rates
the rate of postoperative death
Time frame: up to 30 days after liver resection
Operation time(min)
the during of operation
Time frame: intraoperative
Blood loss(ml)
the volume of blood loss
Time frame: up to 30 days after liver resection
Blood transfusion (times and units)
intraoperative blood transfusion
Time frame: intraoperative
C-reactive protein (mg/mL)
C-reactive protein levels on preoperative and postoperative day-1,3,5
Time frame: up to 5 days after liver resection