Clinical trial NCT03958825: Open Versus Laparoscopic Left Hepatic Sectionectomy
Official title: Randomized Clinical Trial of Open Versus Laparoscopic Left Hepatic Sectionectomy in Treatment of Hepatolithiasis Within an Enhanced Recovery After Surgery Programme
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatolithiasis
Laparoscopic Liver Resection
Open Liver Resection
Enhanced Recovery
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital duration after operation (days)
timeFrame: up to 30 days after liver resection
Secondary outcomes:
measure: Readmission percentage
timeFrame: up to 30 days after liver resection
measure: Total morbidity
timeFrame: up to 1 year after liver resection
measure: Composite endpoint of liver surgery specific morbidity
timeFrame: up to 1 year after liver resection
measure: Hospital and societal costs
timeFrame: up to 1 year after liver resection
measure: Incidence of incisional hernias
timeFrame: up to 1 year after liver resection
measure: Change of serum glutamic oxalacetic transaminase
timeFrame: up to 7 days after liver resection
measure: Change of serum glutamic-pyruvic transaminase
timeFrame: up to 7 days after liver resection
measure: Mortality rates
timeFrame: up to 30 days after liver resection
measure: Operation time(min)
timeFrame: intraoperative
measure: Blood loss(ml)
timeFrame: up to 30 days after liver resection
measure: Blood transfusion (times and units)
timeFrame: intraoperative
measure: C-reactive protein (mg/mL)
timeFrame: up to 5 days after liver resection
Other outcomes:
Locations:
city: Hefei
country: China
facility: The second hospital of Anhui Medical University,
state: Anhui
Study officials:
affiliation: Second Affiliated Hospital of Anhui Medical University
name: hui hou, master
role: STUDY_CHAIR
References: