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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
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomised Controlled Trial of Optimised Surgical Recovery: the Potential Synergy Between Enhanced Gastrointestinal Motility and Oral Nutritional/ Metabolic Support

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: August 2008
Arms Assigned Interventions
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

  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

Locations
Netherlands
University Hospital Maastricht
Maastricht, Netherlands
United Kingdom
Edinburgh Royal Infirmary
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: Paul Hendry, MBChB University of Edinburgh
  More Information

No publications provided by University of Edinburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00538954     History of Changes
Other Study ID Numbers: UEdinburgh
Study First Received: October 2, 2007
Last Updated: November 4, 2010
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Liver Diseases
Laxatives
Magnesium Oxide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013