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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Maastricht University Medical Center
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
UMC Utrecht
Medisch Spectrum Twente
University Medical Centre Groningen
Erasmus Medical Center
University Medical Center Nijmegen
Onze Lieve Vrouwe Gasthuis
Maxima Medical Center
Isala Klinieken
San Raffaele University Hospital, Italy
University Hospital, Aachen
Deventer Ziekenhuis
Information provided by (Responsible Party):
E.M. Wong-Lun-Hing, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00874224
First received: March 31, 2009
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Colorectal Cancer
Liver Metastasis
Liver Disease
Procedure: laparoscopic left lateral hepatic sectionectomy
Procedure: open left lateral hepatic sectionectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Time to functional Recovery [ Time Frame: Date the functional recovery criteria are met ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Postoperative length of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    including readmission <30 days

  • Readmission percentage [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Readmission percentage during one year follow-up

  • Total morbidity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Factors delaying discharge after functional recovery will be monitored.


Estimated Enrollment: 110
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
patients undergoing open left lateral hepatic sectionectomy
Procedure: open left lateral hepatic sectionectomy
open left lateral hepatic sectionectomy
Active Comparator: 2
patients undergoing a laparoscopic left lateral hepatic sectionectomy
Procedure: laparoscopic left lateral hepatic sectionectomy
laparoscopic left lateral hepatic sectionectomy
Active Comparator: 3
Prospective registry of patients that cannot be randomized (both open and laparoscopic left lateral hepatic sectionectomy)
Procedure: laparoscopic left lateral hepatic sectionectomy
laparoscopic left lateral hepatic sectionectomy
Procedure: open left lateral hepatic sectionectomy
open left lateral hepatic sectionectomy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874224

Contacts
Contact: Ronald M van Dam, MD 0031433876543 r.vandam@mumc.nl
Contact: Cornelis HC Dejong, MD, PhD 0031433876543 chc.dejong@mumc.nl

Locations
Netherlands
Maastricht University Medical Centre Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
UMC Utrecht
Medisch Spectrum Twente
University Medical Centre Groningen
Erasmus Medical Center
University Medical Center Nijmegen
Onze Lieve Vrouwe Gasthuis
Maxima Medical Center
Isala Klinieken
San Raffaele University Hospital, Italy
University Hospital, Aachen
Deventer Ziekenhuis
Investigators
Study Director: Ronald M van Dam, MD Maastricht University Medical Centre
Principal Investigator: Cornelis HC Dejong, MD, PhD Maastricht University Medical Centre
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: E.M. Wong-Lun-Hing, Drs. R.M. van dam, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00874224     History of Changes
Other Study ID Numbers: MEC 08-2-110
Study First Received: March 31, 2009
Last Updated: April 29, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Colorectal cancer liver metastasis
Benign liver disease

Additional relevant MeSH terms:
Colorectal Neoplasms
Liver Diseases
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014