Open Versus Laparoscopic Left Hepatic Sectionectomy

Enhanced Recovery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03958825
• Other study ID #: 520
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2020
• Source: The Second Hospital of Anhui Medical University
• Contact: hui s hou, master
• Phone: +8615856943673
• Email: aydpanshubo[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: June 1, 2023
• Est. primary completion date: December 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Enhanced Recovery
• Hepatolithiasis
• Laparoscopic Liver Resection
• Open Liver Resection

Intervention

Procedure:
• laparoscopic hepatic sectionectomy
patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme
• open left hepatic sectionectomy
patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme

Locations

Country	Name	City	State
China	The second hospital of Anhui Medical University,	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital duration after operation (days)	the length of hospital stay	up to 30 days after liver resection
Secondary	Readmission percentage	Readmission percentage during one year follow-up	up to 30 days after liver resection
Secondary	Total morbidity	According to The Clavien-Dindo Classification, https://www.assessurgery.com/clavien-dindo-classification/	up to 1 year after liver resection
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mortality rates	the rate of postoperative death	up to 30 days after liver resection
Secondary	Operation time(min)	the during of operation	intraoperative
Secondary	Blood loss(ml)	the volume of blood loss	up to 30 days after liver resection
Secondary	Blood transfusion (times and units)	intraoperative blood transfusion	intraoperative
Secondary	C-reactive protein (mg/mL)	C-reactive protein levels on preoperative and postoperative day-1,3,5	up to 5 days after liver resection