Surgical Recovery After Left Lateral Hepatic Sectionectomy: Laparoscopic Versus Open Surgery.
ORANGE II
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
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Jan 2010
Longer than P75 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2009
CompletedFirst Posted
Study publicly available on registry
April 2, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMarch 9, 2016
March 1, 2016
4.5 years
March 31, 2009
March 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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. 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.
Date the functional recovery criteria are met
Secondary Outcomes (9)
Postoperative length of hospital stay
30 days
Readmission percentage
1 year
Total morbidity
1 year
Composite endpoint of liver surgery specific morbidity
1 year
Quality of life
1 year
- +4 more secondary outcomes
Study Arms (3)
1
ACTIVE COMPARATORpatients undergoing open left lateral hepatic sectionectomy
2
ACTIVE COMPARATORpatients undergoing a laparoscopic left lateral hepatic sectionectomy
3
ACTIVE COMPARATORProspective registry of patients that cannot be randomized (both open and laparoscopic left lateral hepatic sectionectomy)
Interventions
laparoscopic left lateral hepatic sectionectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Inability to give written informed consent.
- Patients undergoing liver resection other than left lateral hepatic sectionectomy.
- Patients with ASA IV-V
- Underlying liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)collaborator
- UMC Utrechtcollaborator
- Medisch Spectrum Twentecollaborator
- University Medical Center Groningencollaborator
- Erasmus Medical Centercollaborator
- University Medical Center Nijmegencollaborator
- Onze Lieve Vrouwe Gasthuiscollaborator
- Maxima Medical Centercollaborator
- Isalacollaborator
- San Raffaele University Hospital, Italycollaborator
- University Hospital, Aachencollaborator
- Deventer Ziekenhuiscollaborator
Study Sites (1)
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ, Netherlands
Related Publications (2)
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.
PMID: 28138958DERIVEDvan 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.
PMID: 22559239DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ronald M van Dam, MD
Maastricht University Medical Centre
- PRINCIPAL INVESTIGATOR
Cornelis HC Dejong, MD, PhD
Maastricht University Medical Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Drs. R.M. van dam
Study Record Dates
First Submitted
March 31, 2009
First Posted
April 2, 2009
Study Start
January 1, 2010
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
March 9, 2016
Record last verified: 2016-03