Trial Information
A Randomised Controlled Trial of Optimised Surgical Recovery: the Potential Synergy Between Enhanced Gastrointestinal Motility and Oral Nutritional/ Metabolic Support
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Outcome Measure:
Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery)
Outcome Time Frame:
Number of hours post surgery
Principal Investigator
Paul Hendry, MBChB
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Edinburgh
Authority:
United Kingdom: Research Ethics Committee
Study ID:
UEdinburgh
NCT ID:
NCT00538954
Start Date:
August 2006
Completion Date:
August 2008
Related Keywords:
- Colorectal Liver Metastases
- Perioperative
- recovery
- nutrition
- enhanced
- laxative
- Neoplasm Metastasis
- Liver Neoplasms