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


N/A
18 Years
80 Years
Not Enrolling
Both
Colorectal Liver Metastases

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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 ╬╝mol/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

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