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
18 Years
80 Years
Both
Colorectal Cancer, Liver Metastasis, Liver Disease
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Outcome Measure:
Time to functional Recovery
Outcome Description:
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.
Outcome Time Frame:
Date the functional recovery criteria are met
Safety Issue:
No
Principal Investigator
Ronald M van Dam, MD
Investigator Role:
Study Director
Investigator Affiliation:
Maastricht University Medical Centre
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
MEC 08-2-110
NCT ID:
NCT00874224
Start Date:
January 2010
Completion Date:
July 2014
Related Keywords:
- Colorectal Cancer
- Liver Metastasis
- Liver Disease
- Colorectal cancer liver metastasis
- Benign liver disease
- Colorectal Neoplasms
- Liver Diseases
- Neoplasm Metastasis
- Liver Neoplasms
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