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)
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedMay 19, 2010
May 1, 2010
11 months
August 5, 2008
May 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
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
Study Arms (2)
Test
EXPERIMENTALOral nutritional supplement: assignment according to consecutive random numbers.
Control
PLACEBO COMPARATORAssignment according to consecutive random numbers.
Interventions
3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fresenius Kabilead
Study Sites (1)
Medical Center Alkmaar
Alkmaar, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul A.M. van Leeuwen, Prof.
University Hospital Amsterdam; The Netherlands
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 5, 2008
First Posted
August 8, 2008
Study Start
December 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
May 19, 2010
Record last verified: 2010-05