Clinical trial NCT00874224: Surgical Recovery After Left Lateral Hepatic Sectionectomy: Laparoscopic Versus Open Surgery.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Liver Metastasis
Liver Disease
Keywords: Colorectal cancer liver metastasis
Benign liver disease
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: UMC Utrecht
name: Medisch Spectrum Twente
name: University Medical Center Groningen
name: Erasmus Medical Center
name: University Medical Center Nijmegen
name: Onze Lieve Vrouwe Gasthuis
name: Maxima Medical Center
name: Isala
name: San Raffaele University Hospital, Italy
name: University Hospital, Aachen
name: Deventer Ziekenhuis
First posted: 2009-04-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Time to functional Recovery
timeFrame: Date the functional recovery criteria are met
Secondary outcomes:
measure: Postoperative length of hospital stay
timeFrame: 30 days
measure: Readmission percentage
timeFrame: 1 year
measure: Total morbidity
timeFrame: 1 year
measure: Composite endpoint of liver surgery specific morbidity
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
measure: Body image and cosmesis
timeFrame: 1 year
measure: Hospital and societal costs
timeFrame: 1 year
measure: Incidence of incisional hernias
timeFrame: 1 year
measure: Reasons for delay of discharge after functional recovery
timeFrame: untill Discharge
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre
name: Ronald M van Dam, MD
role: STUDY_DIRECTOR
affiliation: Maastricht University Medical Centre
name: Cornelis HC Dejong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong-Lun-Hing EM, van Dam RM, van Breukelen GJ, Tanis PJ, Ratti F, van Hillegersberg R, Slooter GD, de Wilt JH, Liem MS, de Boer MT, Klaase JM, Neumann UP, Aldrighetti LA, Dejong CH; ORANGE II Collaborative Group. Randomized clinical trial of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study). Br J Surg. 2017 Apr;104(5):525-535. doi: 10.1002/bjs.10438. Epub 2017 Jan 31.
citation: van Dam RM, Wong-Lun-Hing EM, van Breukelen GJ, Stoot JH, van der Vorst JR, Bemelmans MH, Olde Damink SW, Lassen K, Dejong CH; ORANGE II Study Group. Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS(R) programme (ORANGE II-trial): study protocol for a randomised controlled trial. Trials. 2012 May 6;13:54. doi: 10.1186/1745-6215-13-54.