Optimised Recovery With Accelerated Nutrition and GI Enhancement

Colorectal Liver Metastases Clinical Trial

— ORANGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538954
• Other study ID #: UEdinburgh
• Status: Completed
• Phase: N/A
• First received: October 2, 2007
• Last updated: November 4, 2010
• Start date: August 2006
• Est. completion date: August 2008

Study information

• Verified date: October 2007
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Liver Metastases

Intervention

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

Other:
• Standard ERAS group

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht
United Kingdom	Edinburgh Royal Infirmary	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery)		Number of hours post surgery
Secondary	t ½ Gastric emptying time on the morning of post-operative day 3		Postoperative day 3
Secondary	Length of hospital stay: nights spent in hospital post-op		Until discharge
Secondary	Patient activity level: measured by activPAL® activity meter		postoperative day 2 - 7 and day 30 - 37