Laparoscopic colectomy within an enhanced recovery programme Cancer
Conditions
Interventions
Patients recruited from colorectal outpatient clinic will be randomised to receive either epidural or wound infusion catheter.
Sponsors
Yeovil District Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, aged 18 or over 2. Patients undergoing elective laparoscopic colectomy for right or left sided benign or malignant tumour of the colon, with intention to cure 3. American Society of Anesthesiology score of I, II or III 4. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Transverse colon or rectal tumour 2. Locally advanced (T4) or widespread distant disease. Palpable mass. 3. Emergency admission or obstruction/perforated disease 4. Inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis) 5. Known allergy to local anaesthetic 6. Multiple sclerosis or chronic pain requiring regular strong opiate drugs 7. Recent history of drug or alcohol abuse 8. Contraindication to epidural 9. Poor cognitive ability making consent or completion of questionnaires impossible 10. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient reported pain assessment. This will be assessed at baseline before the operation, on return to the ward after surgery and twice daily at 10.00 and 16.00 on days one and two post operatively. It will then be measured once daily until discharge and in outpatient follow up two weeks post operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rescue analgesia. Analgesia log will be filled in daily by research nurse 2. Patient reported outcomes will be recorded pre operatively as baseline and prior to discharge by the research nurse using a structured questionnaire 3. Quality of life assessment using SF-36® Health Survey and Euroqol EQ-5D at baseline, prior to discharge and at two week follow up 4. A subset of 10 patients will be invited to take part in video recorded interviews at two week follow up to assess the success of blinding and to investigate the patient experience of taking part 5. Complications will be entered into a data sheet at discharge by the research fellow and followed up to 30 days to capture readmission, morbidity and mortality 6. Length of hospital stay will be recorded by the research nurse at discharge 7. Standard performance indicators using short physical performance battery will be assessed by the research nurse at baseline and 48 hours post operatively 8. Stress response to surgery and the effect of analgesic method will be investigated with blood samples taken at baseline, 3, 6, 12 and 24 hours after surgery. This will be performed by the research fellow or on call doctor to a strict protocol. The samples will measure epinephrine, cortisol, insulin and interleukin-6. | — |
Countries
United Kingdom
Outcome results
None listed