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Preoperative Oral Immunonutrition for Patients With Pancreatic Cancer Undergoing Elective Surgery - Effect on Complications and Length of Hospital Stay

Randomized, Controlled Trial Investigating the Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01789073
Enrollment
35
Registered
2013-02-11
Start date
2013-02-28
Completion date
2013-12-31
Last updated
2013-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Postoperative, Complications, Elective, Surgery, GI surgery, Immunonutrition, Immune-enhancing, Immune-modulating, Nutrition, Pancreatic cancer, Postoperative complications and length of hospital stay after major gastrointestinal (GI) elective surgery.

Brief summary

The purpose of this study is to investigate the effect of preoperative immunonutrition on complications and length of hospital stay in patients with pancreatic cancer undergoing elective surgery.

Interventions

DIETARY_SUPPLEMENTOral Impact, Nestlé Health Science

Oral Impact from Nestlé Health Science. An enteral nutritional supplement high in protein and with added immune-enhancing nutrients: arginine, fish oil and nucleotides. The intervention arm receives Oral Impact in an individually estimated dosage according to a protein requirement of 1.5 g/kg bodyweight/day (subtracted their habitual protein intake). Each patient receives this dosage orally the last 7 days prior to surgery.

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Men and women referred to treatment at Surgical Gastroenterology Clinic C, Ward 2122 for pancreatic cancer * Age \> 18 years.

Exclusion criteria

* Age \< 18 years * Pregnant and lactating women * Persons who cannot understand and/or speak Danish * Renal dysfunction * Milk allergy * Participants are excluded if elective surgery is not indicated after all

Design outcomes

Primary

MeasureTime frame
Overall postoperative complications after major gastrointestinal (GI) elective surgery.Within the first 30 days after surgery

Secondary

MeasureTime frame
Length of hospital stay after major gastrointestinal (GI) elective surgeryWithin the first 30 days after surgery

Other

MeasureTime frame
Weight stability, functional capability and patients´ satisfaction with the overall study course.from recruitment and within 30 days after surgery

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026