Traditional open, open fAst track recovery and laParoscopic fASt track multimodal management for surgical patients with colon carcinomas: TAPAS study

ISRCTN ISRCTN44649165
DOI https://doi.org/10.1186/ISRCTN44649165
Secondary identifying numbers N/A
Submission date
13/05/2009
Registration date
24/07/2009
Last edited
10/08/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Jurrian Reurings
Scientific

Dunantstraat 10
Tilburg
5017 KD
Netherlands

Email j.reurings@elisabeth.nl

Study information

Study designProspective observational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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
Study acronymTAPAS study
Study objectivesThe 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(s)METC commission EZ Tilburg approved on the 13th January 2007 (ref: 0665)
Health condition(s) or problem(s) studiedColon carcinoma/colorectal surgery
InterventionCohort 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 typeOther
Primary outcome measureCosts (direct medical and indirect non-medical). Analysed for the in hospital period and time back to work.
Secondary outcome measures1. 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 study start date01/01/2007
Completion date01/01/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants3 x 15 x 5 = 225 participants
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment01/01/2007
Date of final enrolment01/01/2011

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Dunantstraat 10
Tilburg
5017 KD
Netherlands

Sponsor information

St Elisabeth Hospital (St Elisabeth Ziekenhuis) (Netherlands)
Hospital/treatment centre

Hilvarenbeekseweg 60
Tilburg
5022 GC
Netherlands

Website http://www.elisabeth.nl/
ROR logo "ROR" https://ror.org/04gpfvy81

Funders

Funder type

Hospital/treatment centre

St Elisabeth Hospital (St Elisabeth Ziekenhuis) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 14/06/2010 Yes No