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Standard and Immunostimulating Enteral Nutrition in Surgical Patients

Standard and Immunostimulating Enteral Nutrition in Patients After Extended Gastrointestinal Surgery - A Prospective, Randomized, Controlled Clinical Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00576940
Acronym
ImmuniEteral
Enrollment
196
Registered
2007-12-19
Start date
2004-06-30
Completion date
2007-09-30
Last updated
2007-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Pancreatic Cancer

Keywords

enteral nutrition, immunomodulating nutrition

Brief summary

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

Detailed description

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.

Interventions

DRUGReconvan

isocaloric, immunomodulating entral diet

isocaloric, isopeptic standard diet

Sponsors

Jagiellonian University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
The ratio of postoperative complications (infectious and surgical)Postoperative complications

Secondary

MeasureTime frame
function of immune systemfunction of immune system
length of hospital staylength of hospital stay
assessment of liver and kidney functionassessment of liver and kidney function
determination of the treatment tolerancedetermination of the treatment tolerance
assessment of visceral protein turnoverassessment of visceral protein turnover

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026