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Clinical Trials/NCT00730808
NCT00730808
Completed
Not Applicable

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

Fresenius Kabi1 site in 1 country20 target enrollmentDecember 2008
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ConditionsRectal Tumors

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectal Tumors
Sponsor
Fresenius Kabi
Enrollment
20
Locations
1
Primary Endpoint
Immunoinflammatory parameters
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
November 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Immunoinflammatory parameters

Time Frame: on day -2, -1, 1, 2, 3, 5, and 7

Ischemia / reperfusion injury parameters

Time Frame: on day -2, 1, 3, 5, and 7

Antioxidant / oxidant parameters

Time Frame: on day -2, 1, 3, 5, and 7

Secondary Outcomes

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

Study Sites (1)

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