Contact information
Type
Scientific
Primary contact
Mr Jurrian Reurings
ORCID ID
Contact details
Dunantstraat 10
Tilburg
5017 KD
Netherlands
j.reurings@elisabeth.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
TAPAS study
Study hypothesis
The TAPAS study is likely to indicate the treatment programme which is most cost minimising in the participating hospitals. Together with the evidence on equality of long term clinical effectiveness (from literature), it will justify or reject hospital investments on fast track and/or laparoscopic programmes. Dissemination of the outcome to other hospitals may have a major impact on medical expense nationwide.
Ethics approval
METC commission EZ Tilburg approved on the 13th January 2007 (ref: 0665)
Study design
Prospective observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Colon carcinoma/colorectal surgery
Intervention
Cohort 1: Conventional open surgery is the control exposure
Cohort 2: Open surgery with fast track recovery
Cohort 3: Laparoscopic surgery with fast track recovery
Three separate time periods are used in order to prevent attrition bias. Before each new cohort starts a quality control will be carried out by the expert project advisors from the research group on fast track recovery and laparoscopic surgery. The overall follow-up is 1 year.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Costs (direct medical and indirect non-medical). Analysed for the in hospital period and time back to work.
Secondary outcome measures
1. Mortality
2. Post-operative morbidity
3. Complications (early complications less than 30 days post-operative; late complications 30 - 52 days post-operative)
4. Surgical-oncological resection margins
5. Hospital stay
6. Time back to recovery/work
7. Cosmesis
9. Pain and health status
10. Quality of life
All outcome measures and in particular quality of life is measured pre-operation and at 6, 12 and 52 weeks post-operation.
Overall trial start date
01/01/2007
Overall trial end date
01/01/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female patients with malignant disease of the colon with indication to elective surgical resection
2. Aged 18 years or older
3. Reasonable to good health (American Society of Anaesthesiologists [ASA] grade I or II)
4. No known relevant allergies
5. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3 x 15 x 5 = 225 participants
Participant exclusion criteria
1. Pregnancy
2. Aged under 18 years
3. Moderate to severe systemic disease (ASA III and higher)
4. History of previous upper abdominal surgery
5. History of previous abdominal surgery
6. Psychiatric disease or inability to assess follow up (e.g. lack of knowledge of the Dutch language)
Recruitment start date
01/01/2007
Recruitment end date
01/01/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Dunantstraat 10
Tilburg
5017 KD
Netherlands
Sponsor information
Organisation
St Elisabeth Hospital (St Elisabeth Ziekenhuis) (Netherlands)
Sponsor details
Hilvarenbeekseweg 60
Tilburg
5022 GC
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
St Elisabeth Hospital (St Elisabeth Ziekenhuis) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20546569
Publication citations
-
Results
Reurings JC, Spanjersberg WR, Oostvogel HJ, Buskens E, Maring J, Kruijt F, Rosman C, van Duivendijk P, Dejong CH, van Laarhoven CJ, 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)., BMC Surg, 2010, 10, 18, doi: 10.1186/1471-2482-10-18.