![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
Fresenius Kabi |
---|---|
Information provided by: | Fresenius Kabi |
ClinicalTrials.gov Identifier: | NCT00730808 |
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: | Supportive Care, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (PreOP Booster) vs. Placebo in Surgical Patients (Pilot Study) |
Estimated Enrollment: | 20 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Test: Experimental
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;
|
Control: Placebo Comparator
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;
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Steffen Benzing, Dr. | +49 (0) 6172 686 7709 | steffen.benzing@fresenius-kabi.com |
Netherlands | |
Medical Center Alkmaar | |
Alkmaar, Netherlands |
Study Chair: | Paul A.M. van Leeuwen, Prof. | University Hospital Amsterdam; The Netherlands |
Responsible Party: | Kabi Innovation Centre, Fresenius Kabi Deutschland GmbH ( Dr. Steffen Benzing ) |
Study ID Numbers: | N-POB-04-NL |
Study First Received: | August 5, 2008 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00730808 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Enteral nutritional regimen prior to surgery |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms Gastrointestinal Neoplasms Intestinal Diseases |
Rectal cancer Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms Rectal neoplasm |
Neoplasms Neoplasms by Site |