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Laparoscopic versus open liver resection for benign and malignant hepatic lesions in adults

  1. Ahsan M Rao,
  2. Irfan Ahmed*

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 31 MAY 2013

Assessed as up-to-date: 30 AUG 2012

DOI: 10.1002/14651858.CD010162.pub2


How to Cite

Rao AM, Ahmed I. Laparoscopic versus open liver resection for benign and malignant hepatic lesions in adults. Cochrane Database of Systematic Reviews 2013, Issue 5. Art. No.: CD010162. DOI: 10.1002/14651858.CD010162.pub2.

Author Information

  1. NHS Grampian, Department of Surgery, Aberdeen Royal Infirmary, Aberdeen, UK

*Irfan Ahmed, Department of Surgery, Aberdeen Royal Infirmary, NHS Grampian, 21 b Powis Crescent, Aberdeen, AB24 3YY, UK. i.ahmed@doctors.org.uk. irfanahmed2@nhs.net.

Publication History

  1. Publication Status: New
  2. Published Online: 31 MAY 2013

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Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Abu Hilal 2008Non-randomised, comparative analysis with prospective laparoscopic group matched with retrospective open group

Aldrighetti 2008Retrospective, non-randomised comparative analysis

Belli 2007Retrospective, non-randomised comparative analysis

Belli 2009Retrospective, non-randomised comparative analysis

Buell 2004Comparative case series of prospective laparoscopic group

Cai 2008Retrospective, non-randomised comparative analysis

Campos 2009Non-randomised, prospective, observational study (laparoscopic group matched with retrospective open group)

Carswell 2009Retrospective, non-randomised, comparative analysis

Castaing 2009Retrospective, non-randomised, comparative analysis

Dagher 2009Retrospective, non-randomised, comparative analysis

Endo 2009Retrospective, non-randomised, comparative analysis

Farges 2002Non-randomised, comparative cohort study

Ito 2009Retrospective, non-randomised comparative analysis

Kaneko 2005Non-randomised, comparative cohort study

Koffron 2007Retrospective, non-randomised comparative analysis

Laurent 2003Non-randomised, comparative cohort study

Lee 2007Case-control study

Lesurtel 2003Case-control study

Mala 2002Non-randomised, retrospective, comparative study

Mamada 2007Retrospective, non-randomised, comparative analysis

Morino 2003Retrospective, non-randomised, comparative analysis

Polignano 2008Non-randomised, prospective cohort study

Rau 1998Non-randomised, prospective cohort study

Rowe 2009Non-randomised, prospective cohort study

Sarpel 2009Retrospective, matched cohort study

Soubrane 2006Non-randomised comparative study (prospective laparoscopic group matched with retrospective open group)

Tang 2005Retrospective, matched comparative study

Topal 2008Non-randomised, prospective comparative study

Tranchart 2009Non-randomised comparative study

Troisi 2008Retrospective, non-randomised comparative analysis

Tsinberg 2009Case-control study

Vanounou 2010Retrospective, matched cohort study

 
Characteristics of ongoing studies [ordered by study ID]
NCT00874224

Trial name or titleOpen versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERASW programme (ORANGE II – Trial): study protocol for a randomised controlled trial.

MethodsThe ORANGE-II trial is a multi-centred, prospective, randomised, controlled, parallel-group superiority trial with a double-blinded experimental and a prospective registry design to determine whether laparoscopic surgery is to be preferred over open surgery in patients undergoing a left lateral hepatic sectionectomy within an enhanced recovery programme. The experimental design produces 2 randomised arms: (a) open LLS and (b) laparoscopic LLS. Two additional registry arms will be based on surgeons/patients that do not want to be randomised because they have an explicit preference for either the laparoscopic LLS (c), or for the open LLS (d).

ParticipantsInclusion criteria:

  • Patients suitable for undergoing both laparoscopic left lateral sectionectomy as well as open left lateral 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 and 80
  • BMI between 18 and 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.

InterventionsThe experimental design produces 2 randomised arms:

Procedure: laparoscopic left lateral hepatic sectionectomy.
Procedure: open left lateral hepatic sectionectomy.

OutcomesThe primary outcome of the ORANGE II trial is time to functional recovery. The functional recovery criteria consist of adequate pain control with oral analgesics only, mobility restored to an independent level, absence of intravenous fluid administration, ability to eat solid foods and finally a normal or decreasing serum bilirubin level. A patient is fully functionally recovered when all of the 5 criteria are satisfied.

Secondary outcomes of this trial are postoperative length of hospital stay, readmission percentage, (liver-specific) morbidity, quality of life, body image and cosmetic result, hospital and societal costs during 1 year and long-term incidence of incisional hernias.

Starting dateJanuary 2010

Contact informationContact: Ronald M van Dam, MD
Phone: +31 433876543
r.vandam@mumc.nl

Notes

NCT01441856

Trial name or titleThe ORANGE II PLUS - Trial: Open versus laparoscopic hemihepatectomy.

MethodsThe ORANGE II PLUS - trial is a prospective study with a 2-armed, randomised, double-blinded experimental design and registry to determine whether laparoscopic surgery is to be preferred over open surgery in patients undergoing a left or right hemihepatectomy and participating in an enhanced recovery programme.

ParticipantsInclusion criteria:

  • Patients requiring open or laparoscopic left/right hemihepatectomy
  • 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 and 80
  • BMI between 18 and 35
  • Patients with ASA I-II-III.


Exclusion criteria:

  • Inability to give written informed consent
  • Patients undergoing liver resection other than left or right hemihepatectomy
  • Patients with hepatic lesion(s), that are located with insufficient margin from vascular or biliary structures to be operated laparoscopically
  • Patients with ASA IV-V
  • Underlying liver disease: significant fibrosis (METAVIR score F2-F4), indirect signs of CASH (platelet count < 100,000, splenomegaly, severe steatosis)
  • Repeat hepatectomy.


Not willing to participate.

InterventionsTwo groups (left and right) will receive an open hemihepatectomy, and the other 2 groups (left and right) will receive a laparoscopic hemihepatectomy. Patients ineligible for randomisation will be included in a prospective registry. All patients will participate in an enhanced recovery programme.

OutcomesPrimary outcomes: time to functional recovery.

Secondary outcomes: length of hospital stay, total percentage of patients being readmitted total morbidity during 1 year, composite endpoint of liver-specific morbidity (intra-abdominal bleeding, intra-abdominal abscess, ascites, post-resectional liver failure, intra-operative mortality, bile leakage), long-term incidence of incisional hernia, quality of life, body image and cosmesis, and reasons for delay in discharge after functional recovery.

Starting dateJanuary 2012

Contact informationRonald M. van Dam, MD
Telephone: +31 43 387 74 89
r.vandam@mumc.nl

Notes