Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00560846
• Other study ID #: CER: 07-123
• Status: Terminated
• Phase: N/A
• First received: November 19, 2007
• Last updated: September 4, 2013
• Start date: November 2007
• Est. completion date: September 2012

Study information

• Verified date: September 2013
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Neoplasms
• Stomach Neoplasms

Intervention

Dietary Supplement:
• Impact
Preoperative 5 day oral Impact and early post-operative enteral Impact
• Glucose load
Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery

Locations

Country	Name	City	State
Switzerland	Hôpitaux Universitaires Genève	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Dan Azagury

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of post-operative complications		30 days	No
Primary	Length of stay		30 days	No
Secondary	Quality of life		1 year	No
Secondary	Body composition		1 year	No