Colorectal CancerORANGE IINCT00874224
Surgical Recovery After Left Lateral Hepatic Sectionectomy: Laparoscopic Versus Open Surgery.
A study testing laparoscopic left lateral hepatic sectionectomy and open left lateral hepatic sectionectomy in people with Colorectal Cancer and Liver Metastasis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Liver Metastasis, Liver Disease
- What is being tested?
- laparoscopic left lateral hepatic sectionectomy and open left lateral hepatic sectionectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2010to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to give written informed consent.
- Patients undergoing liver resection other than left lateral hepatic sectionectomy.
- Patients with ASA IV-V
- Underlying liver disease
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer, Liver Metastasis, Liver Disease
- Being tested
- laparoscopic left lateral hepatic sectionectomy, open left lateral hepatic sectionectomy
- Keywords
- Colorectal cancer liver metastasis, Benign liver disease
- Medical subject headings
- Colorectal Neoplasms, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic left lateral hepatic sectionectomyProcedure or surgery
laparoscopic left lateral hepatic sectionectomy
open left lateral hepatic sectionectomyProcedure or surgery
open left lateral hepatic sectionectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | patients undergoing open left lateral hepatic sectionectomy Receives: Procedure: open left lateral hepatic sectionectomy |
| 2 | Active comparator | patients undergoing a laparoscopic left lateral hepatic sectionectomy Receives: Procedure: laparoscopic left lateral hepatic sectionectomy |
| 3 | Active comparator | Prospective registry of patients that cannot be randomized (both open and laparoscopic left lateral hepatic sectionectomy) Receives: Procedure: laparoscopic left lateral hepatic sectionectomy; Procedure: open left lateral hepatic sectionectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Date the functional recovery criteria are met
Secondary outcomes (9)
Postoperative length of hospital stay
including readmission <30 days
Measured: 30 days
Readmission percentage
Readmission percentage during one year follow-up
Measured: 1 year
Total morbidity
Morbidity will be classified and analysed according to the validated classification for postoperative morbidity as described by Dindo et al.
Measured: 1 year
Composite endpoint of liver surgery specific morbidity
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.
Measured: 1 year
Quality of life
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.
Measured: 1 year
Body image and cosmesis
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
Measured: 1 year
Hospital and societal costs
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.
Measured: 1 year
Incidence of incisional hernias
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.
Measured: 1 year
Reasons for delay of discharge after functional recovery
Factors delaying discharge after functional recovery will be monitored.
Measured: untill Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startJan 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, R.S. Fichtinger, Maastricht University Medical Center
- Investigators
- Ronald M van Dam, MD, Study director, Maastricht University Medical CentreCornelis HC Dejong, MD, PhD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874224
- Sponsor's protocol ID
- MEC 08-2-110
- Acronym
- ORANGE II
- Status last verified
- Mar 2016
- First submitted
- 31 Mar 2009
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28138958van 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.
PubMed 22559239
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00874224
- Acronym / sponsor ID
- ORANGE II / MEC 08-2-110
- Conditions
- Colorectal Cancer, Liver Metastasis, Liver Disease
- Keywords
- Colorectal cancer liver metastasis, Benign liver disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- 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
- Study start
- Jan 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: open left lateral hepatic sectionectomypatients undergoing open left lateral hepatic sectionectomy |
| 2 | Active comparator | Procedure: laparoscopic left lateral hepatic sectionectomypatients undergoing a laparoscopic left lateral hepatic sectionectomy |
| 3 | Active comparator | Procedure: laparoscopic left lateral hepatic sectionectomy, Procedure: open left lateral hepatic sectionectomyProspective registry of patients that cannot be randomized (both open and laparoscopic left lateral hepatic sectionectomy) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Inability to give written informed consent.
- Patients undergoing liver resection other than left lateral hepatic sectionectomy.
- Patients with ASA IV-V
- Underlying liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic left lateral hepatic sectionectomylaparoscopic left lateral hepatic sectionectomy | Procedure or surgery | 2, 3 |
| open left lateral hepatic sectionectomyopen left lateral hepatic sectionectomy | Procedure or surgery | 1, 3 |
Primary outcome
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.
9 secondary outcomes
Postoperative length of hospital stay
Time frame: 30 days
Readmission percentage
Time frame: 1 year
Total morbidity
Time frame: 1 year
Composite endpoint of liver surgery specific morbidity
Time frame: 1 year
Quality of life
Time frame: 1 year
Body image and cosmesis
Time frame: 1 year
Hospital and societal costs
Time frame: 1 year
Incidence of incisional hernias
Time frame: 1 year
Reasons for delay of discharge after functional recovery
Time frame: untill Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Derived from this study: PubMed 28138958Wong-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.
- Derived from this study: PubMed 22559239van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald M van Dam, MD study director
Maastricht University Medical Centre
Cornelis HC Dejong, MD, PhD principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic left lateral hepatic sectionectomy and open left lateral hepatic sectionectomy in people with Colorectal Cancer and Liver Metastasis, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to functional Recovery (time frame: Date the functional recovery criteria are met). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00874224, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016.