Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery - Full Text View

Sponsored by:	University Hospital, Geneva
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00560846

Purpose

The aim is to demonstrate the influence of peri operative nutrition on the post operative complications, preservation of lean body mass and lenght of stay after gastrectomy or oesophagectomy.

Condition	Intervention
Stomach Neoplasms Esophageal Neoplasms	Dietary Supplement: Impact Dietary Supplement: Glucose load Dietary Supplement: Control

MedlinePlus related topics: Cancer Dietary Supplements Esophageal Cancer Esophagus Disorders Stomach Cancer

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Perioperative Nutrition in Upper GI Cancer Surgery (Oesophagectomy or Gastrectomy)

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

Rate of postoperative complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Lenght of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Body composition [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	95
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2009

Arms	Assigned Interventions
Nutrition: Experimental Pre operative immunonutritrion, Preoperative glucose load, post operative early immunonutrition	Dietary Supplement: Impact Preoperative 5 day oral Impact Dietary Supplement: Glucose load Pre opertative glucose load: 800 ml of PreOp (Nutricia) 12h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery Dietary Supplement: Impact Early postoperative enteral Impact
Control: Active Comparator No immunonutrition, no glucose load, no early enteral immunonutrition	Dietary Supplement: Control No immunonutrition, no glucose load

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Surgery for Upper GI cancer
Age over 18
Informed consent

Exclusion Criteria:

Major swallowing disorders
Dementia or other psychological state precluding compliance and understanding of research protocol
Pre-existing enteral or parenteral nutrition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560846

Contacts

Contact: Dan E Azagury, MD	+41223727704	dan.azagury@hcuge.ch
Contact: Olivier Huber, PD	+41223727704	olivier.huber@hcuge.ch

Locations

Switzerland
Hôpitaux Universitaires Genève	Recruiting
Geneva, Switzerland, 1204

Sponsors and Collaborators

University Hospital, Geneva

Investigators

Principal Investigator:

Dan E Azagury, MD

Geneva University Hospital

More Information

Study ID Numbers:	CER: 07-123
Study First Received:	November 19, 2007
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00560846
Health Authority:	Switzerland: Federal Office of Public Health

Keywords provided by University Hospital, Geneva:

Gastric cancer
Esophageal cancer
Surgical complications
Immunonutrition

Study placed in the following topic categories:

Stomach Diseases
Digestive System Neoplasms
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Head and Neck Neoplasms

Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009