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Completed

NCT Number: NCT00576940

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

1st Deparment of General Surgery

Krakow, Krkaow, 30-798, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reconvan

Drug

isocaloric, immunomodulating entral diet

Other names: oligopeptic immunostimulatory diet

peptisorb

Drug

isocaloric, isopeptic standard diet

Other names: standard enetral diet

Primary outcomes

  1. The ratio of postoperative complications (infectious and surgical)

    Time frame: Postoperative complications

Secondary outcomes

  1. length of hospital stay

    Time frame: length of hospital stay

  2. function of immune system

    Time frame: function of immune system

  3. assessment of liver and kidney function

    Time frame: assessment of liver and kidney function

  4. determination of the treatment tolerance

    Time frame: determination of the treatment tolerance

  5. assessment of visceral protein turnover

    Time frame: assessment of visceral protein turnover

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Acronym: ImmuniEteral

Important dates

Study start
2004
Study completion
2007
First posted
Dec 19, 2007
Registry last updated
Dec 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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