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Open Access Study protocol

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 Reurings1, Willem R Spanjersberg2, Henk JM Oostvogel1, Erik Buskens3, John Maring4, Flip Kruijt5, Camiel Rosman6, Peter van Duivendijk2, Cees HC Dejong7 and Cees JHM van Laarhoven2*

Author Affiliations

1 Department of Surgery, Sint Elisabeth Hospital, Tilburg, the Netherlands

2 Department of Surgery, Universitair Medisch Centrum Radboud., Nijmegen, the Netherlands

3 Department of Epidemiology and Statistics, Universitair Medisch Centrum Utrecht, Utrecht, the Netherlands

4 Department of Surgery, Tweesteden Hospital, Tilburg, the Netherlands

5 Department of Surgery, Gelderse Vallei Ziekenhuis, Ede, the Netherlands

6 Department of Surgery, Canisius Wilhelimina Ziekenhuis, Nijmegen, the Netherlands

7 Department of Surgery, Academisch ziekenhuis Maastricht, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands

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BMC Surgery 2010, 10:18  doi:10.1186/1471-2482-10-18

Published: 14 June 2010

Abstract

Background

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 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/design

The 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.

Discussion

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.

Trial registration

ISRCTN44649165.