Optimised Recovery With Accelerated Nutrition and GI Enhancement (ORANGE)

This study has been completed.
Sponsor:
Collaborator:
NHS Lothian
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00538954
First received: October 2, 2007
Last updated: November 4, 2010
Last verified: October 2007

October 2, 2007
November 4, 2010
August 2006
Not Provided
Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery) [ Time Frame: Number of hours post surgery ]
Same as current
Complete list of historical versions of study NCT00538954 on ClinicalTrials.gov Archive Site
  • t ½ Gastric emptying time on the morning of post-operative day 3 [ Time Frame: Postoperative day 3 ]
  • Length of hospital stay: nights spent in hospital post-op [ Time Frame: Until discharge ]
  • Patient activity level: measured by activPAL® activity meter [ Time Frame: postoperative day 2 - 7 and day 30 - 37 ]
Same as current
Not Provided
Not Provided
 
Optimised Recovery With Accelerated Nutrition and GI Enhancement
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Colorectal Liver Metastases
  • 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
  • Active Comparator: 1
    Follow a standard Enhanced Recovery After Surgery protocol
    Intervention: 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
    Intervention: Drug: Post operative laxation (Magnesium Oxide)
  • 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
    Intervention: Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementation
  • 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
    Interventions:
    • Drug: Post operative laxation (Magnesium Oxide)
    • Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
August 2008
Not Provided

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom
 
NCT00538954
UEdinburgh
No
Not Provided
University of Edinburgh
NHS Lothian
Principal Investigator: Paul Hendry, MBChB University of Edinburgh
University of Edinburgh
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP