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NCT Number: NCT00730808

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

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.

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Key information

Conditions

Rectal Tumors Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Center Alkmaar

Alkmaar, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PreOP Booster (food for special medical purposes)

Dietary Supplement

3x1 dosage is given prior to surgery: 2x1 the day prior to surgery; 1x1 3-4h prior to initiation of anaesthesia;

Primary outcomes

  1. Immunoinflammatory parameters

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

  2. Antioxidant / oxidant parameters

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

  3. Ischemia / reperfusion injury parameters

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

Secondary outcomes

  1. pre-and postoperative discomfort (well-being)

    Time frame: on day -1, and 0

  2. hand grip strength

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

  3. GI tolerance

    Time frame: on day -1, 0, 1, 2, and 7

  4. Safety

    Time frame: on day -1, 0, 1, 2, 3, 5, and 7

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 8, 2008
Registry last updated
May 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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