Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery

Fresenius Kabi

Status: Completed

Conditions: Rectal Tumors

Treatments: Dietary Supplement: PreOP Booster (food for special medical purposes)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00730808

N-POB-04-NL

Details and patient eligibility

About

The aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low anterior resection.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• rectal tumour with indication for elective low anterior resection (open surgery, not laparoscopic surgery) or abdominoperineal resection (APR)
• preoperative radiotherapy (5x5 Gy) or chemoradiation
• loop ileostoma or colostoma;

Exclusion criteria

• severe malnutrition
• severe renal insufficiency
• diabetes mellitus I or II
• concomitant thyroid medication
• corticosteroids
• diuretic medication and antihypertensive medication
• known or suspected allergy to any component of the investigational product(s)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 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 (food for special medical purposes)

Control

Placebo Comparator group

Description:

Assignment according to consecutive random numbers.

Treatment:

Dietary Supplement: PreOP Booster (food for special medical purposes)