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Optimised Recovery With Accelerated Nutrition and GI Enhancement

NCT ID: NCT00538954

Last Updated: 2010-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Liver Metastases

Keywords

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Perioperative recovery nutrition enhanced laxative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Follow a standard Enhanced Recovery After Surgery protocol

Group Type ACTIVE_COMPARATOR

Standard ERAS group

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Post operative laxation (Magnesium Oxide)

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Preoperative metabolic conditioning postoperative nutritional supplementation

Intervention Type 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

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

Group Type EXPERIMENTAL

Post operative laxation (Magnesium Oxide)

Intervention Type DRUG

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

Preoperative metabolic conditioning postoperative nutritional supplementation

Intervention Type 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

Interventions

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Post operative laxation (Magnesium Oxide)

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

Intervention Type DRUG

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

Intervention Type DIETARY_SUPPLEMENT

Standard ERAS group

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Principal Investigators

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Paul Hendry, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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University Hospital Maastricht

Maastricht, , Netherlands

Site Status

Edinburgh Royal Infirmary

Edinburgh, , United Kingdom

Site Status

Countries

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Netherlands United Kingdom

References

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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.

Reference Type DERIVED
PMID: 20602497 (View on PubMed)

Other Identifiers

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UEdinburgh

Identifier Type: -

Identifier Source: org_study_id