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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rectal Tumors

Intervention / Treatment
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* Dietary Supplement: PreOP Booster (food for special medical purposes)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Oral nutritional supplement: assignment according to consecutive random numbers. | Dietary Supplement: PreOP Booster (food for special medical purposes)<br>* 3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;<br>|
| Placebo Comparator: Control<br>Assignment according to consecutive random numbers. | Dietary Supplement: PreOP Booster (food for special medical purposes)<br>* 3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enteral nutritional regimen prior to surgery