Open Versus Laparoscopic Left Hepatic Sectionectomy

Not Applicable

• Conditions: Hepatolithiasis; Laparoscopic Liver Resection; Open Liver Resection; Enhanced Recovery
• Interventions: Procedure: laparoscopic hepatic sectionectomy; Procedure: open left hepatic sectionectomy

• Registration Number: NCT03958825
• Lead Sponsor: The Second Hospital of Anhui Medical University

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.

Study Timeline

• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-22
• Study Start: 2019-08-10
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18
• Primary Completion: 2022-12-26
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic hepatic sectionectomy	laparoscopic hepatic sectionectomy	patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme
open left hepatic sectionectomy	open left hepatic sectionectomy	patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme

Primary Outcome Measures

Name	Time	Method
Hospital duration after operation (days)	up to 30 days after liver resection	the length of hospital stay

Secondary Outcome Measures

Name	Time	Method
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.
Blood transfusion (times and units)	intraoperative	intraoperative blood transfusion
Readmission percentage	up to 30 days after liver resection	Readmission percentage during one year follow-up
Total morbidity	up to 1 year after liver resection	According to The Clavien-Dindo Classification, https://www.assessurgery.com/clavien-dindo-classification/
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
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-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.
C-reactive protein (mg/mL)	up to 5 days after liver resection	C-reactive protein levels on preoperative and postoperative day-1,3,5

Trial Locations

Locations (1)

The second hospital of Anhui Medical University,; 🇨🇳 Hefei, Anhui, China