Optimised Recovery With Accelerated Nutrition and GI Enhancement (ORANGE)

A Randomised Controlled Trial of Optimised Surgical Recovery: the Potential Synergy Between Enhanced Gastrointestinal Motility and Oral Nutritional/ Metabolic Support

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Liver Metastases
• Intervention / Treatment: Other: Standard ERAS group; Drug: Post operative laxation (Magnesium Oxide); Dietary supplement: Preoperative metabolic conditioning postoperative nutritional supplementation

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • University Hospital Maastricht
• United Kingdom
  • Edinburgh, United Kingdom, EH16 4SA
    • Edinburgh Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; Follow a standard Enhanced Recovery After Surgery protocol	Other: Standard ERAS group
EXPERIMENTAL: 2; 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	Drug: Post operative laxation (Magnesium Oxide); 20 ml of Magnesium Oxide twice daily from the day after surgery until discharge
EXPERIMENTAL: 3; 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	Dietary supplement: Preoperative 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
EXPERIMENTAL: 4; 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	Drug: Post operative laxation (Magnesium Oxide); 20 ml of Magnesium Oxide twice daily from the day after surgery until discharge; Dietary supplement: Preoperative 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: NHS Lothian
• Investigators: Principal Investigator: Paul Hendry, MBChB, University of Edinburgh

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Study Completion (ACTUAL): August 1, 2008

Study Registration Dates

• First Submitted: October 2, 2007
• First Submitted That Met QC Criteria: October 2, 2007
• First Posted (ESTIMATE): October 3, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): November 5, 2010
• Last Update Submitted That Met QC Criteria: November 4, 2010
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: nutrition; Perioperative; recovery; laxative; enhanced
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Magnesium Oxide
• Other Study ID Numbers: UEdinburgh