Standard and Immunostimulating Enteral Nutrition in Surgical Patients
NCT ID: NCT00576940
Last Updated: 2007-12-19
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
PHASE4
196 participants
INTERVENTIONAL
2004-06-30
2007-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Material and Methods: 196 patients undergoing resection for pancreatic and gastric cancer were randomized in double-blind manner to receive early postoperative enteral nutrition with immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3 fatty acids) or oligopeptic control (SEN group) between June 2004 and September 2007. Enteral nutrition was started 6 hours after surgery and continued for 7 days, up to target volume of 100 ml/h. All malnourished patients requiring preoperative nutritional therapy were excluded for the study and treated preoperatively. Outcome measures were: number and type of complications, length of hospital stay, mortality, treatment tolerance, liver and kidney function.
Results: One hundred eighty-three patients (91 in SEN, 92 in IMEN group, 69 F, 114 M, mean age 61.2) of 196 initially enrolled were analyzed. There were 2 deaths in both groups. Median postoperative hospital stay was 12.4 days (SD 5.9) in SEN group and 12.9 days (SD 8.0) in IMEN group (p=0.42). Complications were observed in 21 patients (23.1%) in SEN and 23 (25.2%) in IMEN group (p\>0.05). 4 (4.4%) patients in SEN group and 4 (4.4%) in IMEN had surgical complications (p\>0.05). There were no differences in liver and kidney function, visceral protein concentration and treatment tolerance.
Conclusion: Clinical and laboratory parameters show no benefit of immunomodulating enteral nutrition over standard enteral nutrition in patients after major gastrointestinal surgery as far as complications, hospital stay, mortality and treatment tolerance and safety are considered.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IMEN: 1
Enteral nutrition with immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3 fatty acids)
Reconvan
isocaloric, immunomodulating entral diet
SEN
postoperative enteral nutrition - standard oligopeptic diet
Peptisorb
isocaloric, isopeptic standard diet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Reconvan
isocaloric, immunomodulating entral diet
Peptisorb
isocaloric, isopeptic standard diet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No severe concomitant disease (heart failure, chronic obstructive pulmonary disease \[COPD\], coronary aortic bypass graft \[CABG\], etc.)
* No history of known allergies or drug intolerance
Exclusion Criteria
* Pregnant
* In poor general status (Karnofsky \<80, Eastern Cooperative Oncology Group (ECOG) \> 1)
* With recent history of severe heart, lung, kidney or liver failure
* With history of allergies or drug intolerance
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jagiellonian University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jagiellonian University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jan Kulig, MD, PhD
Role: STUDY_CHAIR
1st Department of General Surgery
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
1st Deparment of General Surgery
Krakow, Krkaow, Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Braga M, Gianotti L, Nespoli L, Radaelli G, Di Carlo V. Nutritional approach in malnourished surgical patients: a prospective randomized study. Arch Surg. 2002 Feb;137(2):174-80. doi: 10.1001/archsurg.137.2.174.
Klek S, Szybinski P, Szczepanek K. Perioperative immunonutrition in surgical cancer patients: a summary of a decade of research. World J Surg. 2014 Apr;38(4):803-12. doi: 10.1007/s00268-013-2323-z.
Klek S, Sierzega M, Szybinski P, Szczepanek K, Scislo L, Walewska E, Kulig J. The immunomodulating enteral nutrition in malnourished surgical patients - a prospective, randomized, double-blind clinical trial. Clin Nutr. 2011 Jun;30(3):282-8. doi: 10.1016/j.clnu.2010.10.001. Epub 2010 Nov 13.
Klek S, Kulig J, Sierzega M, Szczepanek K, Szybinski P, Scislo L, Walewska E, Kubisz A, Szczepanik AM. Standard and immunomodulating enteral nutrition in patients after extended gastrointestinal surgery--a prospective, randomized, controlled clinical trial. Clin Nutr. 2008 Aug;27(4):504-12. doi: 10.1016/j.clnu.2008.04.010. Epub 2008 Jun 20.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Immunoenteral
Identifier Type: -
Identifier Source: secondary_id
1st Dept Surg Enteral
Identifier Type: -
Identifier Source: org_study_id