Colon carcinoma/colorectal surgery Cancer Malignant neoplasm of rectosigmoid junction
Conditions
Interventions
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
Sponsors
St Elisabeth Hospital (St Elisabeth Ziekenhuis) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Costs (direct medical and indirect non-medical). Analysed for the in hospital period and time back to work. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed