NCT00512213

Brief Summary

The aim of this trial is to compare preoperative Imunnonutrition with standard enteral nutrition regarding morbidity after major abdominal surgery in patients with NRS greater 3. The primary end point is the complication rate until 30 days after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 24, 2012

Status Verified

April 1, 2012

Enrollment Period

3.3 years

First QC Date

August 6, 2007

Last Update Submit

April 21, 2012

Conditions

Major Abdominal Surgery

Keywords

preoperative Immunonutritionmajor abdominal surgerycomplication

Outcome Measures

Primary Outcomes (1)

  • complications after surgery

    30 days

Secondary Outcomes (1)

  • hospital stay, patient compliance, Interleukin-6 and 10 plasma level

    30 days

Study Arms (2)

1

ACTIVE COMPARATOR

Immunonutrition containing RNA, omega-3-FAs, arginine

Dietary Supplement: Immunonutrition for 5 days preoperative

2

ACTIVE COMPARATOR

Standard enteral nutrition: isocaloric and isonitrogeneous but w/o active ingredients

Dietary Supplement: Standard enteral nutrition for 5 days preoperative

Interventions

Immunonutrition for 5 days preoperativeDIETARY_SUPPLEMENT

Impact vs Meritene

Also known as: Impact, Meritene
1
Standard enteral nutrition for 5 days preoperativeDIETARY_SUPPLEMENT

Impact vs Meritene

Also known as: Impact vs Meritene
2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted for elective major abdominal surgery:
  • Open and laparoscopic esophageal, gastric, hepatic, pancreatic, intestinal and colorectal surgery and with a NRS ≥ 3.

You may not qualify if:

  • Age \< 18 years
  • No informed consent
  • Emergency situation
  • Patients not speaking french or german.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Visceral Surgery, University Hospital Center

Lausanne, 1011, Switzerland

Location

MeSH Terms

Interventions

Immunonutrition Diet

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Nicolas Demartines, MD

    Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of surgery

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 7, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 24, 2012

Record last verified: 2012-04

Locations

CH(1)