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

Tracking Information

First Received Date ^ICMJE

November 19, 2007

Last Updated Date

May 11, 2009

Start Date ^ICMJE

November 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Rate of post-operative complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Rate of postoperative complications [ Time Frame: 30 days ]
Lenght of stay [ Time Frame: 30 days ]

Change History

Complete list of historical versions of study NCT00560846 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Quality of life [ Time Frame: 1 year ]
Body composition [ Time Frame: 1 year ]

Descriptive Information

Brief Title ^ICMJE

Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery

Official Title ^ICMJE

Perioperative Nutrition in Upper GI Cancer Surgery (Oesophagectomy or Gastrectomy)

Brief Summary

The aim 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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Stomach Neoplasms
Esophageal Neoplasms

Intervention ^ICMJE

Dietary Supplement: Impact
Dietary Supplement: Glucose load

Study Arms / Comparison Groups

Experimental: Pre-operative immunonutritrion, pre-operative glucose load, post-operative early immunonutrition
No Intervention: No immunonutrition, no glucose load, no early enteral immunonutrition

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00560846

Responsible Party

Principal investigator

Study ID Numbers ^ICMJE

CER: 07-123

Study Sponsor ^ICMJE

University Hospital, Geneva

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Dan E Azagury, MD

Geneva University Hospital

Information Provided By

University Hospital, Geneva

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP