Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery

Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503334

Enrollment

Registered

2007-07-18

Start date

2007-07-31

Completion date

2008-05-31

Last updated

2008-12-08

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

Conditions

Enteral Nutrition (Food for Special Medical Purposes)

Brief summary

The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.

Interventions

DIETARY_SUPPLEMENTpreOP booster (oral nutritional supplement, food for special medical purposes)

3x1 dosage pre-operatively

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Elective pancreaticoduodenectomy

Exclusion criteria

* Concomitant chemotherapy * Severe malnutrition (SGA score C) * Conditions affecting gastric emptying

Design outcomes

Primary

Measure	Time frame
laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;	up to 30 days after surgery

Secondary

Measure	Time frame
postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal tolerance	up to 30 days after surgery

Countries

Italy

Outcome results

None listed

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