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Dietary Supplement

Enteral Nutrition for Post-Pancreatoduodenectomy Care (NUTRIWHI Trial)

N/A
Recruiting
Led By Gaëtan-Romain Joliat, MD
Research Sponsored by University of Lausanne Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient ≥18 years old.
Patient scheduled for elective open pancreatoduodenectomy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperatively and on the day when patients leave the hospital after the operation
Awards & highlights

NUTRIWHI Trial Summary

This trial is testing whether early enteral nutrition (EEN) can reduce postoperative morbidity after pancreatoduodenectomy (PD) compared to oral nutrition.

Who is the study for?
This trial is for adults over 18 who are scheduled for elective pancreatoduodenectomy, at nutritional risk (NRS ≥3), and can give informed consent. It's not suitable for those with language barriers, psychological disorders affecting eating or decision-making, dementia, or if they've already started enteral feeding before surgery.Check my eligibility
What is being tested?
The study is testing whether early enteral nutrition (EEN) after pancreas surgery can improve recovery compared to just oral nutrition. It looks at how EEN affects postoperative complications, hospital stay length, readmission rates, quality of life and the body's response to stress and nutrition.See study design
What are the potential side effects?
While specific side effects aren't detailed here, generally enteral nutrition might cause digestive issues like nausea or bloating. There could also be risks associated with tube placement such as infection or irritation.

NUTRIWHI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am scheduled for surgery to remove part of my pancreas and small intestine.

NUTRIWHI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperatively and at 30 and 90 days after the operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperatively and at 30 and 90 days after the operation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comprehensive Complication Index
Secondary outcome measures
Body composition
Length of stay
Metabolic response to enteral nutrition
+6 more

NUTRIWHI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early enteral nutritionExperimental Treatment1 Intervention
Intervention group: enteral nutrition from the first postoperative night until 50% of caloric requirements are covered by oral nutrition. Enteral nutrition will start at a flow of 250 ml/12h. If tolerated, enteral nutrition will be increased to 500 ml/12h on postoperative day 1, 750 ml/12h on postoperative day 2, and 1000 ml/12h on postoperative day 3. A hypercaloric enteral nutrition will be used (Isosource Energy Fibre or similar).
Group II: Oral nutritionActive Control1 Intervention
Control group: patients will receive standardized oral nutrition. The night after the operation, patients will be allowed to have free drinks. On postoperative day 1, they will receive bouillons, creams, yogurts, and drinks >2 l. On postoperative day 2, they will receive a light diet. On postoperative day 3, they will receive half portion of normal diet and on postoperative day 4 normal diet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Early enteral nutrition
2016
N/A
~120

Find a Location

Who is running the clinical trial?

University of Lausanne HospitalsLead Sponsor
208 Previous Clinical Trials
350,917 Total Patients Enrolled
2 Trials studying Postoperative Complications
350 Patients Enrolled for Postoperative Complications
Nicolas Demartines, MDStudy ChairLausanne University Hospital
6 Previous Clinical Trials
658 Total Patients Enrolled
1 Trials studying Postoperative Complications
200 Patients Enrolled for Postoperative Complications
Markus Schäfer, MDStudy DirectorLausanne University Hospital

Media Library

Early enteral nutrition (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05042882 — N/A
Postoperative Complications Research Study Groups: Early enteral nutrition, Oral nutrition
Postoperative Complications Clinical Trial 2023: Early enteral nutrition Highlights & Side Effects. Trial Name: NCT05042882 — N/A
Early enteral nutrition (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05042882 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being recruited for this medical experiment?

"Clinicaltrials.gov confirms that this clinical trial, originally posted on December 12th 2021, is accepting participants. This listing was last updated on the same day."

Answered by AI

How many participants are currently engaged in this research endeavor?

"Indeed, the details posted to clinicaltrials.gov verify that this investigation is actively searching for participants with an initial posting date of December 12th 2021 and a recent update on the same day. This research project requires 128 individuals from one medical site."

Answered by AI
~19 spots leftby Aug 2024