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Completed

NCT Number: NCT00538954

Optimised Recovery With Accelerated Nutrition and GI Enhancement

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Maastricht, Maastricht, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Post operative laxation (Magnesium Oxide)

Drug

20 ml of Magnesium Oxide twice daily from the day after surgery until discharge

Preoperative metabolic conditioning postoperative nutritional supplementation

Dietary Supplement

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

Standard ERAS group

Other

Primary outcomes

  1. Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery)

    Time frame: Number of hours post surgery

Secondary outcomes

  1. t ½ Gastric emptying time on the morning of post-operative day 3

    Time frame: Postoperative day 3

  2. Length of hospital stay: nights spent in hospital post-op

    Time frame: Until discharge

  3. Patient activity level: measured by activPAL® activity meter

    Time frame: postoperative day 2 - 7 and day 30 - 37

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Lothian

Registry information

Official study title

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

Acronym: ORANGE

Important dates

Study start
2006
Study completion
2008
First posted
Oct 3, 2007
Registry last updated
Nov 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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