NCT00560846

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

4.8 years

First QC Date

November 19, 2007

Last Update Submit

September 4, 2013

Conditions

Stomach NeoplasmsEsophageal Neoplasms

Keywords

Gastric cancerEsophageal cancerSurgical complicationsImmunonutrition

Outcome Measures

Primary Outcomes (2)

  • Rate of post-operative complications

    30 days

  • Length of stay

    30 days

Secondary Outcomes (2)

  • Quality of life

    1 year

  • Body composition

    1 year

Study Arms (2)

Nutrition

EXPERIMENTAL

Pre-operative immunonutritrion, pre-operative glucose load, post-operative early immunonutrition

Dietary Supplement: ImpactDietary Supplement: Glucose load

Control

NO INTERVENTION

No immunonutrition, no glucose load, no early enteral immunonutrition

Interventions

ImpactDIETARY_SUPPLEMENT

Preoperative 5 day oral Impact and early post-operative enteral Impact

Nutrition
Glucose loadDIETARY_SUPPLEMENT

Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery

Also known as: PreOp Nutricia
Nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgery for Upper GI cancer
  • Age over 18
  • Informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires Genève

Geneva, Canton of Geneva, 1204, Switzerland

Location

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Study Officials

  • Dan E Azagury, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medecin adjoint du chef de service

Study Record Dates

First Submitted

November 19, 2007

First Posted

November 20, 2007

Study Start

November 1, 2007

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

CH(1)