Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy

Completed

• Conditions: Digestive Cancer; Surgery; Gastric Cancer; Laparoscopic; Gastric Neoplasm
• Interventions: Dietary Supplement: immunonutrition

• Registration Number: NCT05259488
• Lead Sponsor: University of Rome Tor Vergata

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-02-17
• Last Update Submitted: 2022-02-17
• Study First Posted: 2022-02-28
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients receiving immunonutrition supply	immunonutrition	Dietary Supplement: Immunonutrition nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery

Primary Outcome Measures

Name	Time	Method
30-days postoperative complications	up to 30 days after discharge	Rate of any complication after colorectal resection
LOS	up to 30 days after discharge	number of days between primary colorectal resection and discharge

Secondary Outcome Measures

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