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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00730808
First Posted: August 8, 2008
Last Update Posted: May 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fresenius Kabi
  Purpose
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.

Condition Intervention
Rectal Tumors Dietary Supplement: PreOP Booster (food for special medical purposes)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study)

Resource links provided by NLM:


Further study details as provided by Fresenius Kabi:

Primary Outcome Measures:
  • Immunoinflammatory parameters [ Time Frame: on day -2, -1, 1, 2, 3, 5, and 7 ]
  • Antioxidant / oxidant parameters [ Time Frame: on day -2, 1, 3, 5, and 7 ]
  • Ischemia / reperfusion injury parameters [ Time Frame: on day -2, 1, 3, 5, and 7 ]

Secondary Outcome Measures:
  • pre-and postoperative discomfort (well-being) [ Time Frame: on day -1, and 0 ]
  • hand grip strength [ Time Frame: on day -2, 1, 2, 3, 5, and 7 ]
  • GI tolerance [ Time Frame: on day -1, 0, 1, 2, and 7 ]
  • Safety [ Time Frame: on day -1, 0, 1, 2, 3, 5, and 7 ]

Enrollment: 20
Study Start Date: December 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
Oral nutritional supplement: assignment according to consecutive random numbers.
Dietary Supplement: PreOP 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;
Placebo Comparator: Control
Assignment according to consecutive random numbers.
Dietary Supplement: PreOP 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;

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730808


Locations
Netherlands
Medical Center Alkmaar
Alkmaar, Netherlands
Sponsors and Collaborators
Fresenius Kabi
Investigators
Study Chair: Paul A.M. van Leeuwen, Prof. University Hospital Amsterdam; The Netherlands
  More Information

Responsible Party: Dr. Steffen Benzing, Kabi Innovation Centre, Fresenius Kabi Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00730808     History of Changes
Other Study ID Numbers: N-POB-04-NL
First Submitted: August 5, 2008
First Posted: August 8, 2008
Last Update Posted: May 19, 2010
Last Verified: May 2010

Keywords provided by Fresenius Kabi:
Enteral nutritional regimen prior to surgery

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases