Condition category
Cancer
Date applied
13/05/2009
Date assigned
24/07/2009
Last edited
10/08/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.elisabeth.nl/

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

  1. 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.

Additional files

Editorial Notes