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

Phase 4
18 Years
80 Years
Not Enrolling
Gastric Cancer, Pancreatic Cancer

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Trial Information

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

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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The ratio of postoperative complications (infectious and surgical)

Outcome Time Frame:

Postoperative complications

Safety Issue:


Principal Investigator

Jan Kulig, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

1st Department of General Surgery


Poland: Ministry of Health

Study ID:

1st Dept Surg Enteral



Start Date:

June 2004

Completion Date:

September 2007

Related Keywords:

  • Gastric Cancer
  • Pancreatic Cancer
  • enteral nutrition, immunomodulating nutrition
  • Stomach Neoplasms
  • Pancreatic Neoplasms