Optimised Recovery With Accelerated Nutrition and GI Enhancement (ORANGE)

University of Edinburgh

Status: Completed

Conditions: Colorectal Liver Metastases

Treatments: Drug: Post operative laxation (Magnesium Oxide); Other: Standard ERAS group; Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT00538954

UEdinburgh

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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64 participants in 4 patient groups

1

Active Comparator group

Description:

Follow a standard Enhanced Recovery After Surgery protocol

Treatment:

Other: Standard ERAS group

2

Experimental group

Description:

Follow a standard Enhanced Recovery After Surgery protocol and will receive 1 g of Magnesium Oxide laxative twice daily from the day after surgery until discharge

Treatment:

Drug: Post operative laxation (Magnesium Oxide)

3

Experimental group

Description:

Follow a standard Enhanced Recovery After Surgery protocol and will receive preconditioning with carbohydrate and fluid loading prior to surgery (800ml of Nutricia Preop the evening before surgery and 400 the morning of surgery 2 hours prior to anaesthesia) and postoperative nutritional supplements (200 ml Nutricia Fortisip twice daily) after surgery for 30 days

Treatment:

Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementation

4

Experimental group

Description:

Follow a standard Enhanced Recovery After Surgery protocol and will receive preconditioning with carbohydrate and fluid loading prior to surgery (800ml of Nutricia Preop the evening before surgery and 400 the morning of surgery 2 hours prior to anaesthesia) and postoperative nutritional supplements (200 ml Nutricia Fortisip twice daily) after surgery for 30 days and will receive postoperative laxative in the form of 20 ml of Magnesium Oxide twice daily form the day after surgery until discharge

Treatment:

Drug: Post operative laxation (Magnesium Oxide)

Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementation