Standard and Immunostimulating Enteral Nutrition in Surgical Patients (ImmuniEteral)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer Pancreatic Cancer |
Drug: Reconvan Drug: Peptisorb |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Standard and Immunostimulating Enteral Nutrition in Patients After Extended Gastrointestinal Surgery - A Prospective, Randomized, Controlled Clinical Trial |
- The ratio of postoperative complications (infectious and surgical) [ Time Frame: Postoperative complications ] [ Designated as safety issue: Yes ]
- length of hospital stay [ Time Frame: length of hospital stay ] [ Designated as safety issue: No ]
- function of immune system [ Time Frame: function of immune system ] [ Designated as safety issue: No ]
- assessment of liver and kidney function [ Time Frame: assessment of liver and kidney function ] [ Designated as safety issue: Yes ]
- determination of the treatment tolerance [ Time Frame: determination of the treatment tolerance ] [ Designated as safety issue: Yes ]
- assessment of visceral protein turnover [ Time Frame: assessment of visceral protein turnover ] [ Designated as safety issue: No ]
| Enrollment: | 196 |
| Study Start Date: | June 2004 |
| Study Completion Date: | September 2007 |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Name: oligopeptic immunostimulatory diet
|
|
Active Comparator: SEN
postoperative enteral nutrition - standard oligopeptic diet
|
Drug: Peptisorb
isocaloric, isopeptic standard diet
Other Name: standard enetral diet
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | 1st Department of Surgery, Jagiellonian University |
| ClinicalTrials.gov Identifier: | NCT00576940 History of Changes |
| Other Study ID Numbers: | 1st Dept Surg Enteral, Immunoenteral |
| Study First Received: | December 18, 2007 |
| Last Updated: | December 18, 2007 |
| Health Authority: | Poland: Ministry of Health |
Keywords provided by Jagiellonian University:
|
enteral nutrition, immunomodulating nutrition |
Additional relevant MeSH terms:
|
Stomach Neoplasms Pancreatic Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013