Back to resultsPerioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery
Primary Purpose
Stomach Neoplasms, Esophageal Neoplasms
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Impact
Glucose load
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms focused on measuring Gastric cancer, Esophageal cancer, Surgical complications, Immunonutrition
Eligibility 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
Sites / Locations
- Hôpitaux Universitaires Genève
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutrition
Control
Arm Description
Pre-operative immunonutritrion, pre-operative glucose load, post-operative early immunonutrition
No immunonutrition, no glucose load, no early enteral immunonutrition
Outcomes
Primary Outcome Measures
Rate of post-operative complications
Length of stay
Secondary Outcome Measures
Quality of life
Body composition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00560846
Brief Title
Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery
Official Title
Perioperative Nutrition in Upper GI Cancer Surgery (Oesophagectomy or Gastrectomy)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment over time.
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dan Azagury
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms, Esophageal Neoplasms
Keywords
Gastric cancer, Esophageal cancer, Surgical complications, Immunonutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrition
Arm Type
Experimental
Arm Description
Pre-operative immunonutritrion, pre-operative glucose load, post-operative early immunonutrition
Arm Title
Control
Arm Type
No Intervention
Arm Description
No immunonutrition, no glucose load, no early enteral immunonutrition
Intervention Type
Dietary Supplement
Intervention Name(s)
Impact
Intervention Description
Preoperative 5 day oral Impact and early post-operative enteral Impact
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose load
Other Intervention Name(s)
PreOp Nutricia
Intervention Description
Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery
Primary Outcome Measure Information:
Title
Rate of post-operative complications
Time Frame
30 days
Title
Length of stay
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
1 year
Title
Body composition
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan E Azagury, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires Genève
City
Geneva
ZIP/Postal Code
1204
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery
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