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
Scientific
Dunantstraat 10
Tilburg
5017 KD
Netherlands
| j.reurings@elisabeth.nl |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/01/2007 |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 3 x 15 x 5 = 225 participants |
| 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
5017 KD
Netherlands
Sponsor information
St Elisabeth Hospital (St Elisabeth Ziekenhuis) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Hilvarenbeekseweg 60
Tilburg
5022 GC
Netherlands
| Website | http://www.elisabeth.nl/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
