A prospective cohort study to investigate cost-minimisation, of Traditional open, open fAst track recovery and laParoscopic fASt track multimodal management, for surgical patients with colon carcinomas (TAPAS study)

Jurrian C Reurings,Cees Hc Dejong,Cees Jhm Van Laarhoven,Cees Jhm Van Laarhoven,Camiel Rosman,Erik Buskens,Peter Van Duivendijk,John Maring,Flip Kruijt,Peter Van Duivendijk,Henk Jm Oostvogel,Willem R Spanjersberg

doi:10.1186/1471-2482-10-18

Abstract

BackgroundThe present developments in colon surgery are characterized by two innovations: the introduction of the laparoscopic operation technique and fast recovery programs such as the Enhanced Recovery After Surgery (ERAS) recovery program. The Tapas-study was conceived to determine which of the three treatment programs: open conventional surgery, open 'ERAS' surgery or laparoscopic 'ERAS' surgery for patients with colon carcinomas is most cost minimizing?Method/designThe Tapas-study is a three-arm multicenter prospective cohort study.All patients with colon carcinoma, eligible for surgical treatment within the study period in four general teaching hospitals and one university hospital will be included. This design produces three cohorts: Conventional open surgery is the control exposure (cohort 1). Open surgery with ERAS recovery (cohort 2) and laparoscopic surgery with ERAS recovery (cohort 3) are the alternative exposures. Three separate time periods are used in order to prevent attrition bias.Primary outcome parameters are the two main cost factors: direct medical costs (real cost price calculation) and the indirect non medical costs (friction method). Secondary outcome parameters are mortality, complications, surgical-oncological resection margins, hospital stay, readmission rates, time back to work/recovery, health status and quality of life.Based on an estimated difference in direct medical costs (highest cost factor) of 38% between open and laparoscopic surgery (alfa = 0.01, beta = 0.05), a group size of 3×40 = 120 patients is calculated.DiscussionThe Tapas-study is three-arm multicenter cohort study that will provide a cost evaluation of three treatment programs for patients with colon carcinoma, which may serve as a guideline for choice of treatment and investment strategies in hospitals.Trial registrationISRCTN44649165.

Highlights

The present developments in colon surgery are characterized by two innovations: the introduction of the laparoscopic operation technique and fast recovery programs such as the Enhanced Recovery After Surgery (ERAS) recovery program
The Tapas-study is three-arm multicenter cohort study that will provide a cost evaluation of three treatment programs for patients with colon carcinoma, which may serve as a guideline for choice of treatment and investment strategies in hospitals
Usual care The standard of care for colon carcinoma patients is changing

Summary

Discussion

Extensive literature exists on ERAS and laparoscopic colon surgery. Regarding the comparison between ERAS recovery and conventional care level 1a evidence exists, showing at least equality and possibly improvement of clinical outcome [18]. Four level 1a reports exist on open versus laparoscopic colon surgery[2,3,12,17]: generally short term results of laparoscopic surgery are better, but no differences on middle and long term clinical outcome are found. One level 1b study indicates that ERAS recovery is as effective in open and laparoscopic surgery, which theoretically biases and diminishes the superiority in short term results of laparoscopic compared to open surgery [6]. Abovementioned studies have convincingly shown that the results of ERAS recovery and/or laparoscopic surgery are at least comparable to those of the conventional surgical approach in colon carcinoma. One RCT (level 1b) and three level 2b studies[14,20,24,25] on cost effectiveness of open versus laparoscopic surgery exist.

Background

Methods/design