Major Abdominal SurgeryNCT00512213
Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery
A study testing Immunonutrition for 5 days preoperative and Standard enteral nutrition for 5 days preoperative in people with Major Abdominal Surgery, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Major Abdominal Surgery
- What is being tested?
- Immunonutrition for 5 days preoperative and Standard enteral nutrition for 5 days preoperative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted for elective major abdominal surgery:
- Open and laparoscopic esophageal, gastric, hepatic, pancreatic, intestinal and colorectal surgery and with a NRS ≥ 3.
Who cannot join
- Age < 18 years
- No informed consent
- Emergency situation
- Patients not speaking french or german.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral Surgery, University Hospital Center
Lausanne, 1011
About this study
Official title: Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery: A Single-center Double-blinded Controlled Randomized Superiority Trial
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.
Read the detailed description
Malnutrition affects about 20-50% of all patients in hospital [1, 2]. Major surgery further increases postoperative malnutrition and immunity reduction. Therefore, postoperative complication and infection rates after major surgery exceed 30% [3-6].
The nutritional risk score (NRS) [1] is based on the ESPEN (European society of parenteral and enteral nutrition) screening guidelines and identifies patients who are likely to benefit from nutritional support. Patients with a NRS ≥ 3 are considered severely undernourished, or to have a certain degree of severity of disease in combination with certain degree of malnutrition [7].
In a prospective cohort study patients with a NRS ³ 3 had significant more infectious and overall complications after major abdominal surgery [4, 7, 8]. Several studies showed a benefit by nutritional support on complications [3, 5, 6]. International guidelines suggest therefore preoperative oral nutritional support for malnourished patients undergoing major surgery [9]. However, it remains controversial whether standard enteral nutrition (SEN) or immunonutrition (IN) is preferable [9].
IN, containing arginine, ribonucleic acid and omega-3 polyunsaturated fatty acids aims to improve the nutritional status, immunological function and clinical outcome [5, 10].
- Conditions
- Major Abdominal Surgery
- Being tested
- Immunonutrition for 5 days preoperative, Standard enteral nutrition for 5 days preoperative
- Keywords
- preoperative Immunonutrition, major abdominal surgery, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunonutrition for 5 days preoperativeDietary supplement
Also called Impact, Meritene
Impact vs Meritene
Standard enteral nutrition for 5 days preoperativeDietary supplement
Also called Impact vs Meritene
Impact vs Meritene
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Immunonutrition containing RNA, omega-3-FAs, arginine Receives: Dietary Supplement: Immunonutrition for 5 days preoperative |
| 2 | Active comparator | Standard enteral nutrition: isocaloric and isonitrogeneous but w/o active ingredients Receives: Dietary Supplement: Standard enteral nutrition for 5 days preoperative |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications after surgery
Measured: 30 days
Secondary outcomes (1)
hospital stay, patient compliance, Interleukin-6 and 10 plasma level
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Nicolas DEMARTINES, University of Lausanne Hospitals
- Investigators
- Nicolas Demartines, MD, Study chair, Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512213
- Sponsor's protocol ID
- P00/07 CHV
- Status last verified
- Apr 2012
- First submitted
- 6 Aug 2007
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery: A Single-center Double-blinded Controlled Randomized Superiority Trial
- ClinicalTrials.gov ID
- NCT00512213
- Acronym / sponsor ID
- P00/07 CHV
- Conditions
- Major Abdominal Surgery
- Keywords
- preoperative Immunonutrition, major abdominal surgery, complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Sep 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Malnutrition affects about 20-50% of all patients in hospital [1, 2]. Major surgery further increases postoperative malnutrition and immunity reduction. Therefore, postoperative complication and infection rates after major surgery exceed 30% [3-6].
The nutritional risk score (NRS) [1] is based on the ESPEN (European society of parenteral and enteral nutrition) screening guidelines and identifies patients who are likely to benefit from nutritional support. Patients with a NRS ≥ 3 are considered severely undernourished, or to have a certain degree of severity of disease in combination with certain degree of malnutrition [7].
In a prospective cohort study patients with a NRS ³ 3 had significant more infectious and overall complications after major abdominal surgery [4, 7, 8]. Several studies showed a benefit by nutritional support on complications [3, 5, 6]. International guidelines suggest therefore preoperative oral nutritional support for malnourished patients undergoing major surgery [9]. However, it remains controversial whether standard enteral nutrition (SEN) or immunonutrition (IN) is preferable [9].
IN, containing arginine, ribonucleic acid and omega-3 polyunsaturated fatty acids aims to improve the nutritional status, immunological function and clinical outcome [5, 10].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Immunonutrition for 5 days preoperativeImmunonutrition containing RNA, omega-3-FAs, arginine |
| 2 | Active comparator | Dietary Supplement: Standard enteral nutrition for 5 days preoperativeStandard enteral nutrition: isocaloric and isonitrogeneous but w/o active ingredients |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients admitted for elective major abdominal surgery:
Key exclusion criteria (4 listed)
- Age < 18 years
- No informed consent
- Emergency situation
- Patients not speaking french or german.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunonutrition for 5 days preoperativeAlso: Impact, MeriteneImpact vs Meritene | Dietary supplement | 1 |
| Standard enteral nutrition for 5 days preoperativeAlso: Impact vs MeriteneImpact vs Meritene | Dietary supplement | 2 |
Primary outcome
complications after surgery
Time frame: 30 days
1 secondary outcome
hospital stay, patient compliance, Interleukin-6 and 10 plasma level
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
Related trials for Major Abdominal Surgery
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
Processed Electroencephalography-guided General Anesthesia and Outcomes in Major Abdominal Surgery
Postoperative Acute Kidney Injury
Active, not recruitingPhase 4
Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery
Laparotomy, Bowel Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Demartines, MD study chair
Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunonutrition for 5 days preoperative and Standard enteral nutrition for 5 days preoperative in people with Major Abdominal Surgery, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications after surgery (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2012.