In patients undergoing parenchyma-sparing liver resection for colorectal metastases, laparoscopic surgery was associated with significantly less postoperative complications compared to open surgery. Laparoscopic resection was cost-effective compared to open resection with a 67% probability. The rate of free resection margins was the same in both groups. Our results support the continued implementation of laparoscopic liver resection.
BackgroundLaparoscopic liver resection is used in specialized centers all over the world. However, laparoscopic liver resection has never been compared with open liver resection in a prospective, randomized trial.Methods/DesignThe Oslo-CoMet Study is a randomized trial into laparoscopic versus open liver resection for the surgical management of hepatic colorectal metastases. The primary outcome is 30-day perioperative morbidity. Secondary outcomes include 5-year survival (overall, disease-free and recurrence-free), resection margins, recurrence pattern, postoperative pain, health-related quality of life, and evaluation of the inflammatory response. A cost-utility analysis of replacing open surgery with laparoscopic surgery will also be performed. The study includes all resections for colorectal liver metastases, except formal hemihepatectomies, resections where reconstruction of vessels/bile ducts is necessary and resections that need to be combined with ablation. All patients will participate in an enhanced recovery after surgery program. A biobank of liver and tumor tissue will be established and molecular analysis will be performed.DiscussionAfter 35 months of recruitment, 200 patients have been included in the trial. Molecular and immunology data are being analyzed. Results for primary and secondary outcome measures will be presented following the conclusion of the study (late 2015). The Oslo-CoMet Study will provide the first level 1 evidence on the benefits of laparoscopic liver resection for colorectal liver metastases.Trial registrationThe trial was registered in ClinicalTrals.gov (NCT01516710) on 19 January 2012.
My special appreciation goes to a talented surgeon, my colleague and friend Dr. Åsmund Fretland, who has been a remarkable co-supervisor to me. Your research and surgical skills, positiveness and the ability to solve problems quickly have always impressed me. Thank you for letting me to take over your work in the OSLO-COMET trial and for introducing me to all the details. It is always my great pleasure to draft articles together with you, be your assistant at liver surgery and attend conferences together with you. My classmate, colleague and friend Dr. Mushegh Sahakyan deserves my deepest gratitude. You are a role model for me as a young talented and hard-working researcher. I have learned a lot from our discussions about surgical procedures, article drafting, methodologies and statistics in research. I am very glad that you are back to Norway and our research group. I look forward to continuing our fruitful cooperation and Armenian barbeques together. I would like to thank Prof. Erik Fosse for the opportunity to work at the Intervention Centre, where you have created an outstanding multi-speciality research team. Communication with multidisciplinary research teams and professionals at IVS have extended my horizons. It was my pleasure to work alongside Marianne Berg, Linda Engvik, nurses and radiology team.
Objective: We conducted a randomized, controlled, noninferiority trial to investigate if intravenous, multimodal, patient-controlled analgesia (IV-PCA) could be noninferior to multimodal thoracic epidural analgesia (TEA) in patients undergoing open liver surgery. Summary Background Data: The increasing use of minimally invasive techniques and fast track protocols have questioned the position of epidural analgesia as the optimal method of pain management after abdominal surgery. Methods: Patients operated with open liver resection between February 2012 and February 2016 were randomly assigned to receive either IV-PCA enhanced with ketorolac/diclofenac (IV-PCA, n = 66) or TEA (n = 77) within an enhanced recovery after surgery protocol. Noninferiority would be declared if the mean pain score on the numeric rating scale (NRS) for postoperative days (PODs) 0 to 5 in the IV-PCA group was no worse than the mean pain score in the TEA group by a margin of <1 point on an 11-point scale (0–10). Results: The primary endpoint, mean NRS pain score was 1.7 in the IV-PCA group and 1.6 in the TEA group, establishing noninferiority. Pain scores were lower in the TEA group on PODs 0 and 1, but higher or equal on PODs 2 and 5. Postoperative hospital stay was significantly shorter for patients in the IV-PCA group (74 vs 104 h, P < 0.001). The total opioid consumption during the first 3 days was significantly lower in the IV-PCA group. Conclusions: IV-PCA was noninferior to TEA for the treatment of postoperative pain in patients undergoing open liver resection.
Background Most treatments for cancer cause a decline in patients' health‐related quality of life (HRQoL). Limiting this decline is a universal goal for healthcare providers. Using minimally invasive instead of open surgical techniques might be one way to achieve this. The aim of this study was to compare postoperative HRQoL after open and laparoscopic liver resection. Methods This was a predefined substudy of an RCT comparing open with laparoscopic liver resection. Patients with colorectal liver metastases were assigned randomly to open or laparoscopic parenchyma‐sparing liver resection. HRQoL was assessed with the Short Form 36 questionnaire at baseline, and 1 and 4 months after surgery. Results A total of 280 patients were randomized, of whom 273 underwent surgery (129 laparoscopic, 144 open); 682 questionnaires (83.3 per cent) were available for analysis. One month after surgery, patients in the laparoscopic surgery group reported reduced scores in two HRQoL domains (physical functioning and role physical), whereas those in the open surgery group reported reduced scores in five domains (physical functioning, role physical, bodily pain, vitality and social functioning). Four months after surgery, HRQoL scores in the laparoscopic group had returned to preoperative levels, whereas patients in the open group reported reduced scores for two domains (role physical and general health). The between‐group difference was statistically significant in favour of laparoscopy for four domains after 1 month (role physical, bodily pain, vitality and social functioning) and for one domain after 4 months (role physical). Conclusion Patients assigned to laparoscopic liver surgery reported better postoperative HRQoL than those assigned to open liver surgery. For role limitations caused by physical health problems, patients in the laparoscopic group reported better scores up to 4 months after surgery. Registration number: NCT01516710 ( http://www.clinicaltrials.gov).
Background: Economic analyses of end-of-life care often focus on single aspects of care in selected cohorts leading to limited knowledge on the total level of care required to patients at their end-of-life. We aim at describing the living situation and full range of health care provided to patients at their end-of-life, including how informal care affects formal health care provision, using the case of colorectal cancer. Methods: All colorectal cancer decedents between 2009 and 2013 in Norway (n = 7695) were linked to six national registers. The registers included information on decedents' living situation (days at home, in short-or long-term institution or in the hospital), their total health care utilization and costs in the secondary, primary and home-and community-based care setting. The effect of informal care was assessed through marital status (never married, currently married, or previously married) using regression analyses (negative binominal, two-part models and generalized linear models), controlling for age, gender, comorbidities, education, income, time since diagnosis and year of death. Results: The average patient spent four months at home, while he or she spent 27 days in long-term institutions, 16 days in short-term institutions, and 21 days in the hospital. Of the total costs (~NOK 400,000), 58, 3 and 39% were from secondary carers (hospitals), primary carers (general practitioners and emergency rooms) and home-and community-based carers (home care and nursing homes), respectively. Compared to the never married, married patients spent 30 more days at home and utilized less home-and community-based care, but more health care services at the secondary and primary health care level. Their total healthcare costs were significantly lower (−NOK 65,621) than the never married. We found similar, but weaker, patterns for those who had been married previously. Conclusion: End-of-life care is primarily provided in the secondary and home-and community-based care level, and informal caregivers have a substantial influence on formal end-of-life care provision. Excluding aspects of care such as home and community-based care or informal care in economic analyses of end-of-life care provides a biased picture of the total resources required, and might lead to inefficient resource allocations.
Hemiarthroplasty was a cost-effective treatment. Trial registration, NCT00464230.
Background Limited knowledge exists on the expected long-term effects and cost-effectiveness of initiatives aiming to reduce the burden of obesity. Aim To develop a Norwegian obesity-focused disease-simulation model: the MOON model. Material and Methods We developed a Markov model and simulated a Norwegian birth cohort’s movement between the health states “normal weight,”“overweight,”“obese 1,”“obese 2,” and “dead” using a lifetime perspective. Model input was estimated using longitudinal data from health surveys and real-world data (RWD) from local and national registers ( N = 99,348). The model is deterministic and probabilistic and stratified by gender. Model validity was assessed by estimating the cohort’s expected prevalence, health care costs, and mortality related to overweight and obesity. Results Throughout the cohort’s life, the prevalence of overweight increased steadily and stabilized at 45% at 45 y of age. The number of obese 1 and 2 individuals peaked at age 75 y, when 44% of women and 35% of men were obese. The incremental costs per person associated with obesity was highest in older ages and, when accumulated over the lifetime, higher among women (€12,118, €9,495–€15,047) than men (€6,646, €5,252–€10,900). On average, obesity shortened the life expectancy of women/men in the whole cohort by 1.31/1.08 y. The life expectancy for normal-weight women/men at age 30 was 83.31/80.31. The life expectancy was reduced by 1.05/0.65 y if the individual was overweight, obese (2.87/2.71 y), or obese 2 (4.06/4.83 y). Conclusion The high expected prevalence of obesity in the future will lead to substantial health care costs and large losses in life-years. This underscores the need to implement interventions to reduce the burden of obesity; the MOON model will enable economic evaluations for a wide range of interventions.
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