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

Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00730808

Enrollment

Registered

2008-08-08

Start date

2008-12-31

Completion date

2009-11-30

Last updated

2010-05-19

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

Conditions

Rectal Tumors

Keywords

Enteral nutritional regimen prior to surgery

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTPreOP Booster (food for special medical purposes)

3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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)

Design outcomes

Primary

Measure	Time frame
Immunoinflammatory parameters	on day -2, -1, 1, 2, 3, 5, and 7
Antioxidant / oxidant parameters	on day -2, 1, 3, 5, and 7
Ischemia / reperfusion injury parameters	on day -2, 1, 3, 5, and 7

Secondary

Measure	Time frame
pre-and postoperative discomfort (well-being)	on day -1, and 0
Safety	on day -1, 0, 1, 2, 3, 5, and 7
hand grip strength	on day -2, 1, 2, 3, 5, and 7
GI tolerance	on day -1, 0, 1, 2, and 7

Countries

Netherlands

Outcome results

None listed

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