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Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery

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ClinicalTrials.gov Identifier: NCT00560846
Recruitment Status : Terminated (Insufficient recruitment over time.)
First Posted : November 20, 2007
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of this study is to demonstrate the influence of peri-operative nutrition on the post-operative complications, preservation of lean body mass and length of stay after gastrectomy or oesophagectomy.

Condition or disease Intervention/treatment
Stomach Neoplasms Esophageal Neoplasms Dietary Supplement: Impact Dietary Supplement: Glucose load

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perioperative Nutrition in Upper GI Cancer Surgery (Oesophagectomy or Gastrectomy)
Study Start Date : November 2007
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Nutrition
Pre-operative immunonutritrion, pre-operative glucose load, post-operative early immunonutrition
Dietary Supplement: Impact
Preoperative 5 day oral Impact and early post-operative enteral Impact
Dietary Supplement: Glucose load
Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery
Other Name: PreOp Nutricia
No Intervention: Control
No immunonutrition, no glucose load, no early enteral immunonutrition


Outcome Measures

Primary Outcome Measures :
  1. Rate of post-operative complications [ Time Frame: 30 days ]
  2. Length of stay [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 1 year ]
  2. Body composition [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560846


Locations
Switzerland
Hôpitaux Universitaires Genève
Geneva, Switzerland, 1204
Sponsors and Collaborators
Dan Azagury
Investigators
Principal Investigator: Dan E Azagury, MD Geneva University Hospital
More Information

Responsible Party: Dan Azagury, Medecin adjoint du chef de service, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00560846     History of Changes
Other Study ID Numbers: CER: 07-123
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Keywords provided by Dan Azagury, University Hospital, Geneva:
Gastric cancer
Esophageal cancer
Surgical complications
Immunonutrition

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases