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Optimised Recovery With Accelerated Nutrition and GI Enhancement (ORANGE)
This study is currently recruiting participants.
Verified by University of Edinburgh, October 2007
Sponsors and Collaborators: University of Edinburgh
NHS Lothian
Information provided by: University of Edinburgh
ClinicalTrials.gov Identifier: NCT00538954
  Purpose

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.


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

MedlinePlus related topics: Dietary Supplements
Drug Information available for: Magnesium Magnesium oxide
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title: A Randomised Controlled Trial of Optimised Surgical Recovery: the Potential Synergy Between Enhanced Gastrointestinal Motility and Oral Nutritional/ Metabolic Support

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery) [ Time Frame: Number of hours post surgery ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 64
Study Start Date: August 2006
Estimated Study Completion Date: August 2008
Arms Assigned Interventions
1: Active Comparator
Follow a standard Enhanced Recovery After Surgery protocol
Other: Standard ERAS group
2: Experimental
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
3: Experimental
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
4: Experimental
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538954

Contacts
Contact: Paul Hendry, MBChB 01312426361 paul.hendry@ed.ac.uk

Locations
Netherlands
University Hospital Maastricht Not yet recruiting
Maastricht, Netherlands
Contact: Ronald VanDam, MD         R.VanDam@surgery.azm.nl    
Sub-Investigator: Stephanie Bukkems            
Principal Investigator: Ronald VanDam, MD            
United Kingdom
Edinburgh Royal Infirmary Recruiting
Edinburgh, United Kingdom, EH16 4SA
Principal Investigator: Paul Hendry, MBChB            
Queens Medical Centre Not yet recruiting
Nottingham, United Kingdom
Contact: Dileep N Lobo, MD         Dileep.Lobo@nottingham.ac.uk    
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: Paul Hendry, MBChB University of Edinburgh
  More Information

Trial website  This link exits the ClinicalTrials.gov site

Study ID Numbers: UEdinburgh
Study First Received: October 2, 2007
Last Updated: October 2, 2007
ClinicalTrials.gov Identifier: NCT00538954  
Health Authority: United Kingdom: Research Ethics Committee;   United Kingdom: National Health Service

Keywords provided by University of Edinburgh:
Perioperative
recovery
nutrition
enhanced
laxative

Study placed in the following topic categories:
Magnesium Oxide
Neoplasm Metastasis

Additional relevant MeSH terms:
Neoplasms
Neoplastic Processes
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Antacids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009