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
Protocol serial number	N/A
Sponsor	St Elisabeth Hospital (St Elisabeth Ziekenhuis) (Netherlands)
Funder	St Elisabeth Hospital (St Elisabeth Ziekenhuis) (Netherlands)

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

Primary study design	Observational
Study design	Prospective observational cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
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
Study acronym	TAPAS study
Study objectives	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(s)	METC commission EZ Tilburg approved on the 13th January 2007 (ref: 0665)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Costs (direct medical and indirect non-medical). Analysed for the in hospital period and time back to work.
Key secondary outcome measure(s)	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.
Completion date	01/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	225
Key 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
Key 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)
Date of first enrolment	01/01/2007
Date of final enrolment	01/01/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

Dunantstraat 10

Tilburg
5017 KD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes