Optimised Recovery With Accelerated Nutrition and GI Enhancement

Not Applicable

Completed

• Conditions: Colorectal Liver Metastases
• Interventions: Other: Standard ERAS group; Drug: Post operative laxation (Magnesium Oxide); Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementation

• Registration Number: NCT00538954
• Lead Sponsor: University of Edinburgh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Status Verified: 2007-10
• Study First Submitted: 2007-10-02
• Study First Submitted QC: 2007-10-02
• Study First Posted: 2007-10-03
• Study Completion: 2008-08
• Last Update Submitted: 2010-11-04
• Last Update Posted: 2010-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Standard ERAS group	Follow a standard Enhanced Recovery After Surgery protocol
2	Post operative laxation (Magnesium Oxide)	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
3	Preoperative metabolic conditioning postoperative nutritional supplementation	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
4	Post operative laxation (Magnesium Oxide)	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
4	Preoperative metabolic conditioning postoperative nutritional supplementation	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

Primary Outcome Measures

Name	Time	Method
Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery)	Number of hours post surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Edinburgh Royal Infirmary; 🇬🇧 Edinburgh, United Kingdom

University Hospital Maastricht; 🇳🇱 Maastricht, Netherlands