Clinical trial NCT00538954: Optimised Recovery With Accelerated Nutrition and GI Enhancement
Official title: A Randomised Controlled Trial of Optimised Surgical Recovery: the Potential Synergy Between Enhanced Gastrointestinal Motility and Oral Nutritional/ Metabolic Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Liver Metastases
Keywords: Perioperative
recovery
nutrition
enhanced
laxative
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2007-10-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery)
timeFrame: Number of hours post surgery
Secondary outcomes:
measure: t ½ Gastric emptying time on the morning of post-operative day 3
timeFrame: Postoperative day 3
measure: Length of hospital stay: nights spent in hospital post-op
timeFrame: Until discharge
measure: Patient activity level: measured by activPAL® activity meter
timeFrame: postoperative day 2 - 7 and day 30 - 37
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
city: Edinburgh
country: United Kingdom
facility: Edinburgh Royal Infirmary
Study officials:
affiliation: University of Edinburgh
name: Paul Hendry, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hendry PO, van Dam RM, Bukkems SF, McKeown DW, Parks RW, Preston T, Dejong CH, Garden OJ, Fearon KC; Enhanced Recovery After Surgery (ERAS) Group. Randomized clinical trial of laxatives and oral nutritional supplements within an enhanced recovery after surgery protocol following liver resection. Br J Surg. 2010 Aug;97(8):1198-206. doi: 10.1002/bjs.7120.