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Surgical Recovery After Left Lateral Hepatic Sectionectomy: Laparoscopic Versus Open Surgery. (ORANGE II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00874224
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : March 9, 2016
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
UMC Utrecht
Medisch Spectrum Twente
University Medical Center Groningen
Erasmus Medical Center
University Medical Center Nijmegen
Onze Lieve Vrouwe Gasthuis
Maxima Medical Center
Isala
San Raffaele University Hospital, Italy
University Hospital, Aachen
Deventer Ziekenhuis
Information provided by (Responsible Party):
R.S. Fichtinger, Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE March 31, 2009
First Posted Date  ICMJE April 2, 2009
Last Update Posted Date March 9, 2016
Study Start Date  ICMJE January 2010
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2011)
Time to functional Recovery [ Time Frame: Date the functional recovery criteria are met ]
The functional recovery criteria consist of adequate pain control with oral analgetics 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 five criteria are satisfied. It is medically justified to discharge patients when the criteria for full functional recovery are met and if the patient is willing to go home.
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
  • Functional Recovery [ Time Frame: date functional recovery criteria are met ]
  • Hospital length of stay [ Time Frame: date of discharge ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2011)
  • Postoperative length of hospital stay [ Time Frame: 30 days ]
    including readmission <30 days
  • Readmission percentage [ Time Frame: 1 year ]
    Readmission percentage during one year follow-up
  • Total morbidity [ Time Frame: 1 year ]
    Morbidity will be classified and analysed according to the validated classification for postoperative morbidity as described by Dindo et al.
  • Composite endpoint of liver surgery specific morbidity [ Time Frame: 1 year ]
    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.
  • Quality of life [ Time Frame: 1 year ]
    To assess quality of life the Dutch version of the EQ-5D (EuroQol Group) status test in Dutch centres and the translated EQ-5D for international centres will be used. Furthermore, the EORTC QLQ-C30 with the LM21 module will be used for liver specific treatment measurements. Assessment of the patients' quality of life will be performed at the time of consent, discharge and 10 days, 3, 6 and 12 months after discharge.
  • Body image and cosmesis [ Time Frame: 1 year ]
    To evaluate differences in postoperative body image and cosmesis, the Body image Questionnaire (BIQ) will be used. The BIQ consists of 8 questions regarding body image and cosmesis. The body image assessment will be performed preoperatively at time of consent. Both the body image and the cosmesis assessment will take place at discharge, 10 days, 3 months, 6 months and 12 months after discharge
  • Hospital and societal costs [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year ]
    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.
  • Reasons for delay of discharge after functional recovery [ Time Frame: untill Discharge ]
    Factors delaying discharge after functional recovery will be monitored.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
  • Quality of life [ Time Frame: at the time of consent, discharge and 3 and 12 months after discharge ]
  • Morbidity according to classification of Dindo [ Time Frame: 1 year ]
  • Body image and cosmesis [ Time Frame: at time of consent and at 12 months after discharge ]
  • Hospital costs [ Time Frame: 1 year ]
  • Long term incidence of incisional hernias [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgical Recovery After Left Lateral Hepatic Sectionectomy: Laparoscopic Versus Open Surgery.
Official Title  ICMJE The ORANGE II Trial: An International Multicenter Randomised Controlled Trial of Optimised Surgical Recovery After Left Lateral Hepatic Sectionectomy: Open Versus Laparoscopic Surgery Within an Enhanced Recovery Programme
Brief Summary The ORANGE II trial is a double blinded randomised controlled trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic sectionectomy in terms of time to functional recovery, hospital length of stay, quality of life, readmission percentage, morbidity and mortality, hospital costs, body image and cosmesis, and long term incidence of incisional hernias.
Detailed Description

Recent developments in liver surgery include the introduction of laparoscopic surgery and enhanced recovery programmes. Laparoscopic surgery and enhanced recovery programmes both focus on faster recovery and consequently shorter hospital length of stay.

The ORANGE-II trial is a 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 two randomised arms; (a) open LLS and (b) laparoscopic LLS. An additional registry arm will be based on surgeons/patients that do not want to be randomised because they have an explicit preference for either the laparoscopic LLS or for the open LLS (c).

The primary endpoint of the ORANGE II trial is time to functional recovery. The functional recovery criteria consist of adequate pain control with oral analgetics 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 five criteria are satisfied.

Secondary endpoints 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 one year and long-term incidence of incisional hernias.

The ORANGE-II trial is a randomised controlled multicentre trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic sectionectomy and participating in an enhanced recovery programme.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Liver Metastasis
  • Liver Disease
Intervention  ICMJE
  • Procedure: laparoscopic left lateral hepatic sectionectomy
    laparoscopic left lateral hepatic sectionectomy
  • Procedure: open left lateral hepatic sectionectomy
    open left lateral hepatic sectionectomy
Study Arms  ICMJE
  • Active Comparator: 1
    patients undergoing open left lateral hepatic sectionectomy
    Intervention: Procedure: open left lateral hepatic sectionectomy
  • Active Comparator: 2
    patients undergoing a laparoscopic left lateral hepatic sectionectomy
    Intervention: Procedure: laparoscopic left lateral hepatic sectionectomy
  • Active Comparator: 3
    Prospective registry of patients that cannot be randomized (both open and laparoscopic left lateral hepatic sectionectomy)
    Interventions:
    • Procedure: laparoscopic left lateral hepatic sectionectomy
    • Procedure: open left lateral hepatic sectionectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 1, 2013)
110
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2009)
120
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion 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 18-80.
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00874224
Other Study ID Numbers  ICMJE MEC 08-2-110
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R.S. Fichtinger, Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • UMC Utrecht
  • Medisch Spectrum Twente
  • University Medical Center Groningen
  • Erasmus Medical Center
  • University Medical Center Nijmegen
  • Onze Lieve Vrouwe Gasthuis
  • Maxima Medical Center
  • Isala
  • San Raffaele University Hospital, Italy
  • University Hospital, Aachen
  • Deventer Ziekenhuis
Investigators  ICMJE
Study Director: Ronald M van Dam, MD Maastricht University Medical Centre
Principal Investigator: Cornelis HC Dejong, MD, PhD Maastricht University Medical Centre
PRS Account Maastricht University Medical Center
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP