Surgical Recovery After Left Lateral Hepatic Sectionectomy: Laparoscopic Versus Open Surgery. (ORANGE II)
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| ClinicalTrials.gov Identifier: NCT00874224 |
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Recruitment Status :
Completed
First Posted : April 2, 2009
Last Update Posted : March 9, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer Liver Metastasis Liver Disease | Procedure: laparoscopic left lateral hepatic sectionectomy Procedure: open left lateral hepatic sectionectomy | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 110 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Care Provider) |
| 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 |
| Study Start Date : | January 2010 |
| Actual Primary Completion Date : | July 2014 |
| Actual Study Completion Date : | July 2014 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
patients undergoing open left lateral hepatic sectionectomy
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Procedure: open left lateral hepatic sectionectomy
open left lateral hepatic sectionectomy |
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Active Comparator: 2
patients undergoing a laparoscopic left lateral hepatic sectionectomy
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Procedure: laparoscopic left lateral hepatic sectionectomy
laparoscopic left lateral hepatic sectionectomy |
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Active Comparator: 3
Prospective registry of patients that cannot be randomized (both open and laparoscopic left lateral hepatic sectionectomy)
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Procedure: laparoscopic left lateral hepatic sectionectomy
laparoscopic left lateral hepatic sectionectomy Procedure: open left lateral hepatic sectionectomy open left lateral hepatic sectionectomy |
- 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.
- Postoperative length of hospital stay [ Time Frame: 30 days ]including readmission <30 days
- Readmission percentage [ Time Frame: 1 year ]Readmission percentage during one year follow-up
- Total morbidity [ Time Frame: 1 year ]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 ]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 ]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 ]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 ]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 ]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 ]Factors delaying discharge after functional recovery will be monitored.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874224
| Netherlands | |
| Maastricht University Medical Centre | |
| Maastricht, Limburg, Netherlands, 6202 AZ | |
| Study Director: | Ronald M van Dam, MD | Maastricht University Medical Centre | |
| Principal Investigator: | Cornelis HC Dejong, MD, PhD | Maastricht University Medical Centre |
| Responsible Party: | R.S. Fichtinger, Drs. R.M. van dam, Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00874224 |
| Other Study ID Numbers: |
MEC 08-2-110 |
| First Posted: | April 2, 2009 Key Record Dates |
| Last Update Posted: | March 9, 2016 |
| Last Verified: | March 2016 |
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Colorectal cancer liver metastasis Benign liver disease |
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Colorectal Neoplasms Neoplasm Metastasis Liver Diseases 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 |