Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery
NCT ID: NCT00730808
Last Updated: 2010-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2008-12-31
2009-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery
NCT00662376
Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery
NCT00503334
Nutritional Support in Patients Undergoing Surgical Treatment of Colorectal Cancer
NCT03930888
PeRioperative Optimization With Nutritional Supplements for Patients Undergoing GastRointEStinal Surgery for Cancer
NCT03445260
Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery
NCT07268846
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Test
Oral nutritional supplement: assignment according to consecutive random numbers.
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;
Control
Assignment according to consecutive random numbers.
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;
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* preoperative radiotherapy (5x5 Gy) or chemoradiation
* loop ileostoma or colostoma;
Exclusion Criteria
* 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)
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fresenius Kabi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kabi Innovation Centre, Fresenius Kabi Deutschland GmbH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul A.M. van Leeuwen, Prof.
Role: STUDY_CHAIR
University Hospital Amsterdam; The Netherlands
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Center Alkmaar
Alkmaar, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
N-POB-04-NL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.