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

Not Applicable

Completed

• Conditions: Rectal Tumors
• Interventions: Dietary Supplement: PreOP Booster (food for special medical purposes)

• Registration Number: NCT00730808
• Lead Sponsor: Fresenius Kabi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Study Start: 2008-12
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-18
• Last Update Posted: 2010-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	PreOP Booster (food for special medical purposes)	Oral nutritional supplement: assignment according to consecutive random numbers.
Control	PreOP Booster (food for special medical purposes)	Assignment according to consecutive random numbers.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical Center Alkmaar; 🇳🇱 Alkmaar, Netherlands