Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery

Fresenius Kabi

Status: Completed

Conditions: Enteral Nutrition Regimen Prior to Surgery

Treatments: Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662376

N-POB-01-UK

Details and patient eligibility

About

The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective laparoscopic cholecystectomy

Exclusion criteria

• bile duct stones
• ileus
• conditions affecting gastric emptying
• severe, organ-specific disorders
• HIV
• inherited metabolic disorders
• known intolerance against or allergy to any component of the investigational feeds

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups, including a placebo group

Test

Experimental group

Description:

oral nutritional supplement (assignment: according to consecutive random numbers)

Treatment:

Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)

Control

Placebo Comparator group

Description:

placebo (assignment: according to consecutive random numbers)

Treatment:

Dietary Supplement: PreOP Booster (oral nutritional supplement, food for special medical purposes)