Authors: Jacob Gehrman Ingela Björholt Eva Angenete John Andersson Jaap Bonjer Eva Haglind
Publish Date: 2016/07/15
Volume: 31, Issue: 3, Pages: 1225-1234
Abstract
A prospective costminimization analysis was carried out by using data of clinical resource use from the randomized controlled trial COLOR II Some data needed for the health economic evaluation were not collected in the clinical trial therefore a retrospective data collection was made for COLOR IIpatients operated at the largest participating Swedish hospital n = 105 Sick leave information was provided by the Swedish social insurance agency Unit costs were collected from Swedish sources The primary outcome was the difference in mean cost between laparoscopic and open surgeryThe COLOR IItrial enrolled 1044 rectal cancer patients randomized between laparoscopic and open surgery 21 At the 3year followup data for the clinical variables used in the analysis were available for 74–89 of patients Laparoscopic surgery costs the health care sector more than the open technique both at 28 days 1910 95 CI 677–3143 and 3 years 3854 95 CI 1527–6182 after surgery There were however no differences in longterm costs to society between laparoscopic and open surgery 684 95 CI −5799 to 7166Though the study found short and longterm cost differences for the healthcare sector there was no difference in regard to the longterm societal perspective Future research is suggested to investigate the effects of sick leave costs using material from a greater number of patientsSeveral smaller series and one large randomized trial the COLOR COlorectal cancer Laparoscopic or Open Resection IItrial 1 have shown that laparoscopic surgery for rectal cancer has shortterm benefits and is safe in comparison to open surgery The shortterm outcomes of the COLOR IItrial found that the laparoscopic group had less blood loss and a shorter hospital stay but longer operating room time 2 The analysis of the primary endpoint showed no difference with regard to locoregional recurrence rates There was no statistically significant difference in 3year survival between the surgical procedures 3 The study continues to monitor the diseasefree and overall survival rates 5 years after surgery The shortterm outcomes of the ACOSOG Z6051 4 and ALaCaRT 5 randomized clinical trials of laparoscopic and open rectal cancer resections failed to establish noninferiority in terms of the pathological and adequate surgical resection outcomes These trials have however used other endpoints both are shortterm and the group sizes are such that clinically relevant longterm oncological results cannot be ascertainedUncertainties remain regarding the relative costs of laparoscopic and open rectal cancer surgery Several studies performed alongside randomized trials comparing the costs of laparoscopic and open surgery for rectal cancer have had short time perspectives 6 7 8 9 or have not included the cost of sick leave 8 9 10 the results are difficult to interpret from a societal viewpointThe aim of the present study was to evaluate the cost of laparoscopic versus open resection for rectal cancer from both the healthcare and the societal perspective based on the randomized COLOR IItrial The health economic method employed was a costminimization analysis see health economic methodology The costs were assessed at 28 days shortterm analysis and 3 years longterm analysis The hypothesis was that laparoscopic surgery would be more costly when assessed at 28 days after the primary operation but not at 3 yearsThe COLOR IItrial provided the clinical data for the present cost study 11 The study was designed as a noninferiority trial undertaken at thirty hospitals in eight countries Belgium Canada Denmark Germany the Netherlands Spain Sweden and South Korea between January 2004 and May 2010 11 The patients were randomized on a 21 basis 699 patients in the laparoscopic resection group and 345 in the open resection group The trial was stratified by center location of tumor and radiotherapy prior to surgery 2 11 During the course of the trial clinical record forms CRF were administered one each for the pre intra and postoperative stages up to 28 days after the operation and one CRF per year up to 5 years after the index surgery In case of complications reoperations or recurrences an additional CRF was completed At the primary endpoint data were available for 771 patients 74 regarding locoregional recurrence and for 903 patients 87 concerning overall survival 3 The institutional review board at each participating center approved the trial All patients provided informed consent in writing
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