Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy

Study Overview
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Brief Summary
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Immunonutrition (IN) appears to reduce infective complications and in-hospital length of stay (LOS) after gastrointestinal surgery. More specifically, it seems to be beneficial also in gastric cancer surgery. Potential benefits of combining preoperative IN (PIN) with protocols of enhanced recovery after surgery (ERAS) in reducing LOS in laparoscopic total gastrectomy are yet to be determined.

Official Title
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Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy: a Single-centre Comparative Study

Conditions
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Gastric Cancer, Surgery, Laparoscopic, Gastric Neoplasm, Digestive Cancer

Intervention / Treatment
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* Dietary Supplement: immunonutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Primary gastric cancer Preoperative staging I-III Eligible for laparoscopic D2 total gastrectomy Exclusion Criteria: Acquired or congenital immunodeficiency Malnutrition (MNA-SF score < 12) Preoperative infection Previous gastric surgery ASA IV Emergency setting Para-aortic node involvement Intraoperative evidence of distant metastasis or peritoneal carcinosis Conversion to open surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients receiving immunonutrition supply<br>Dietary Supplement: Immunonutrition nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery | Dietary Supplement: immunonutrition<br>* nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery<br>|
| historical control group<br>standard dietary advice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-days postoperative complications | Rate of any complication after colorectal resection | up to 30 days after discharge | 
| LOS | number of days between primary colorectal resection and discharge | up to 30 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leak | rate of any postoperative leakage of oesophagojejunal, jejunojejunal anastomosis, clinically, radiologically or endoscopically demonstrated | up to 30 days after discharge | 
| Pneumonia | rate of radiologically demonstrated pneumonia | up to 30 days after discharge | 
| Ileus | rate of any ileus clinically demonstrated | up to 30 days after discharge | 
| Prolonged length of stay | rate of any patient discharged after 15 days | up to 30 days after discharge | 
| Readmission | Rate of any unplanned readmission after discharge | up to 30 days after discharge | 
| Mortality | Rate of any mortality | up to 30 days after discharge | 
| Time of first defacation | time to first bowel opened to stool | up to 30 days after discharge | 
| Time of tolerated fluid intake | time to first tolerated fluid intake | up to 30 days after discharge | 
| Time of tolerated food intake | time to first tolerated food intake | up to 30 days after discharge |