Optimised Recovery With Accelerated Nutrition and GI Enhancement

NCT00538954 | Completed

• 1 other identifier: UEdinburgh
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Perioperative; recovery; nutrition; enhanced; laxative

Outcome Measures

Primary Outcomes (1)

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

  Number of hours post surgery

Secondary Outcomes (3)

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

  Postoperative day 3

• Length of hospital stay: nights spent in hospital post-op

  Until discharge

• Patient activity level: measured by activPAL® activity meter

  postoperative day 2 - 7 and day 30 - 37

Study Arms (4)

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)

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

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); Dietary Supplement: Preoperative metabolic conditioning postoperative nutritional supplementation

Interventions

Post operative laxation (Magnesium Oxide) DRUG

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

2; 4

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

3; 4

Standard ERAS group OTHER

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (2)

University Hospital Maastricht

Maastricht, Netherlands

Location

Edinburgh Royal Infirmary

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (1)

• 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. doi: 10.1002/bjs.7120.

  PMID: 20602497 DERIVED

MeSH Terms

Interventions

Magnesium Oxide

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Paul Hendry, MBChB

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2007
• First Posted: October 3, 2007
• Study Start: August 1, 2006
• Study Completion: August 1, 2008
• Last Updated: November 5, 2010

Record last verified: 2007-10

Locations

GB (1); NL (1)