Colorectal Liver Metastases
Conditions
Keywords
Perioperative, recovery, nutrition, enhanced, laxative
Brief summary
Factors which delay recovery following uncomplicated abdominal surgery include uncontrolled pain, intolerance of diet and poor mobility. Enhanced recovery after Surgery (ERAS) programmes are perioperative care pathways that address systematically these issues (i.e. improved dynamic pain relief, optimised nutritional care and enforced mobilisation) to promote a faster recovery and a shorter stay. The key treatments that improve outcome within an ERAS programme are not known. Moreover there are few acceptable, objective endpoints to assess key outcome variables such as return of GI function. This randomised trial will assess the potential synergy between early recovery of GI function (laxation) and early postoperative oral nutritional support(with associated preoperative preconditioning using carbohydrate/fluid loading). The main overall outcome targets being improved recovery of gastrointestinal function, postoperative nutritional status and physical function. It will validate the use of a novel, objective technique to measure gastric motility (surrogate for GI function). Such refinement of ERAS should result in shorter hospital stay and better use of limited health care resource.
Interventions
DRUGPost operative laxation (Magnesium Oxide)
20 ml of Magnesium Oxide twice daily from the day after surgery until discharge
DIETARY_SUPPLEMENTPreoperative metabolic conditioning postoperative nutritional supplementation
Nutricia PreOP drinks 800 ml between 8-10 pm the evening before surgery Nutricia PreOP drinks 400 ml completed 2 hours before anaesthesia on the morning of surgery Nutricia Fortisip drinks 2 x 200 ml drinks from the day after surgery until day 30
OTHERStandard ERAS group
Sponsors
NHS Lothian
University of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing hepatic resection for benign or malignant conditions * Able to understand the nature of the study and what will be required of them. * Men and non-pregnant, non-lactating women * BMI 18 - 30
Exclusion criteria
* Inability to give written, informed consent * Patients with dementia or neurological impairment * Patients with pre-existing condition limiting mobility * Planned bile duct excision * Repeat or staged procedures * Central extended resections * Underlying cirrhotic liver disease * Jaundice (Bilirubin \> 50 μmol/L)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery) | Number of hours post surgery |
Secondary
| Measure | Time frame |
|---|---|
| t ½ Gastric emptying time on the morning of post-operative day 3 | Postoperative day 3 |
| Length of hospital stay: nights spent in hospital post-op | Until discharge |
| Patient activity level: measured by activPAL® activity meter | postoperative day 2 - 7 and day 30 - 37 |
Countries
Netherlands, United Kingdom
Outcome results
None listed