Colorectal cancer Cancer Colorectal cancer
Conditions
Interventions
Randomisation procedures:
After completing suitability checks and consent forms for a patient, the site staff will call or fax a dedicated telephone to confirm the eligibility of the patient. The pati
Sponsors
University of Oxford and North West London Hospitals NHS Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of colorectal cancer (any stage) 2. Suitable for elective resection following a planned admission 3. Greater than or equal to 18 years of age 4. Written informed consent given
Exclusion criteria
Exclusion criteria: 1. Acute intestinal obstruction 2. Unplanned admission to hospital 3. Unsuitability for epidural insertion - determined pre-randomisation 4. Pregnant 5. Unsuitable for laparoscopic resection as conversion to open surgery is likely, e.g., fixed tumours or rectosigmoid cancers which have a 'threatened margin' (defined as tumour at or within 1 mm of the circumferential resection margin) on preoperative imaging 6. Previous complex laparotomies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative fatigue assessment using the 20-item Multidimensional Fatigue Inventory (MFI-20) which will be completed prior to randomisation and sent by post at 4 weeks, 3 and 6 months following surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Postoperative hospital stay: counting the day of operation as zero 2. Complications: 30 day morbidity will be assessed by the Research Nurse using a standardised definition of complications by blinded review within the first week and outpatient review at 2 and 4 weeks. 30 day readmission and reoperation rates, along with 30 day and in-hospital mortality will also be recorded 3. Patient reported and functional outcomes: self-reported quality of life will be assessed using the 36-item Short Form questionnaire. Questionnaires will be completed before randomisation and then sent by post at 4 weeks, 3 and 6 months following surgery. Standardised objective Performance Indicators (SPIs) using a standard test of lower limb strength, balance and endurance that takes approximately 5 minutes to measure - at the same time intervals as Quality of Life 4. Cosmetic outcomes: in order to assess the impact of surgery on the appearance of the body and the patient's confidence, a body image questionnaire will be completed preoperatively and one year after operation. Cosmetic outcome will be assessed using a body image scale calculated from questionnaires 5. Health economics outcomes: a health resource questionnaire will be completed for all patients providing information about the use of healthcare post-operatively for 6 months. Data collected will include General Practitioner (GP) surgery visits, GP home visits, District Nurse visits, inpatient hotel costs (including re-admission and re-operation within 28 days and convalescent care), operating theatre costs, drug costs, outpatient visits, physiotherapy and occupational therapy, hospital transport and the use of the service provisions. In addition, EuroQol (EQ5D) questionnaires will be used at the defined follow up intervals. Questionnaires to be completed post-operatively and then sent by post at 2 weeks, 4 weeks, 3 months and 6 months after surgery | — |
Countries
United Kingdom
Outcome results
None listed