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

Rectal Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730808
• Other study ID #: N-POB-04-NL
• Status: Completed
• Phase: N/A
• First received: August 5, 2008
• Last updated: May 18, 2010
• Start date: December 2008
• Est. completion date: November 2009

Study information

• Verified date: May 2010
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Rectal Tumors

Intervention

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;

Locations

Country	Name	City	State
Netherlands	Medical Center Alkmaar	Alkmaar

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunoinflammatory parameters		on day -2, -1, 1, 2, 3, 5, and 7	No
Primary	Antioxidant / oxidant parameters		on day -2, 1, 3, 5, and 7	No
Primary	Ischemia / reperfusion injury parameters		on day -2, 1, 3, 5, and 7	No
Secondary	pre-and postoperative discomfort (well-being)		on day -1, and 0	No
Secondary	hand grip strength		on day -2, 1, 2, 3, 5, and 7	No
Secondary	GI tolerance		on day -1, 0, 1, 2, and 7	No
Secondary	Safety		on day -1, 0, 1, 2, 3, 5, and 7	No