Standard And Immunostimulating Enteral Nutrition In Surgical Patients

Study Overview

Standard and Immunostimulating Enteral Nutrition in Surgical Patients

The aim of the study was to assess the clinical effect of immunomodulating enteral nutrition in patients undergoing resection for gastrointestinal cancer. 196 subjects were randomly assigned into two study groups: standard and immunostimulating. The study failed to demonstrate any clear advantage of routine postoperative immunonutrition in patients undergoing elective upper gastrointestinal surgery

Background&Aim: The administration of immunomodulating enteral diets during postoperative period in patients after major gastrointestinal surgery is intended to reduce the number of postoperative complications and to shorten the hospital stay. The aim of the study was to assess the clinical effect of enteral immunostimulatory nutrition in surgical patients. 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.

Gastric Cancer
Pancreatic Cancer

DRUG: Reconvan
DRUG: Peptisorb

1st Dept Surg Enteral
Immunoenteral

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-12-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2007-12-18
First Submitted that Met QC Criteria 2007-12-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2007-12-19
First Posted (ESTIMATED) 2007-12-19	Results First Posted N/A	Last Verified 2007-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: IMEN: 1 Enteral nutrition with immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3 fatty acids)	DRUG: Reconvan isocaloric, immunomodulating entral diet
ACTIVE_COMPARATOR: SEN postoperative enteral nutrition - standard oligopeptic diet	DRUG: Peptisorb isocaloric, isopeptic standard diet

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: IMEN: 1

Enteral nutrition with immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3 fatty acids)

DRUG: Reconvan

isocaloric, immunomodulating entral diet

ACTIVE_COMPARATOR: SEN

postoperative enteral nutrition - standard oligopeptic diet

DRUG: Peptisorb

isocaloric, isopeptic standard diet

Primary Outcome Measures	Measure Description	Time Frame
The ratio of postoperative complications (infectious and surgical)		Postoperative complications

Secondary Outcome Measures	Measure Description	Time Frame
length of hospital stay		length of hospital stay
function of immune system		function of immune system
assessment of liver and kidney function		assessment of liver and kidney function
determination of the treatment tolerance		determination of the treatment tolerance
assessment of visceral protein turnover		assessment of visceral protein turnover

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Adults aged 18-80 years undergoing subtotal and total gastric resection with lymphadenectomy and pancreatoduodenectomy/ total pancreatectomy with lymphadenectomy, in good general status (Karnofsky > 80, Eastern Cooperative Oncology Group (ECOG) grade 0 or 1); with no confirmed neoplastic dissemination nor distant metastases
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

Patients with metastatic or unresectable disease
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Jan Kulig, MD, PhD, 1st Department of General Surgery

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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