NCT00538954

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Liver Metastases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-08-01
• Completion: 2008-08-01
• First posted: 2007-10-03
• Last updated: 2010-11-05

Locations

2 sites across 2 countries: Netherlands, United Kingdom