Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Surgery; Gastric Neoplasm; Digestive Cancer; Laparoscopic
• Intervention / Treatment: Dietary supplement: immunonutrition

• Study Type: Observational
• Enrollment (Actual): 51

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All normonourished patients undergoing elective ERAS laparoscopic total gastrectomy for cancer at Minimally Invasive Surgery Unit of Tor Vergata University Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients receiving immunonutrition supply; Dietary Supplement: Immunonutrition nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery	Dietary supplement: immunonutrition; nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery
historical control group; standard dietary advice

What is the study measuring?

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
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
Anastomotic leak	rate of any postoperative leakage of oesophagojejunal, jejunojejunal anastomosis, clinically, radiologically or endoscopically 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

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata

Publications and helpful links

General Publications

• Franceschilli M, Siragusa L, Usai V, Dhimolea S, Pirozzi B, Sibio S, Di Carlo S. Immunonutrition reduces complications rate and length of stay after laparoscopic total gastrectomy: a single unit retrospective study. Discov Oncol. 2022 Jul 11;13(1):62. doi: 10.1007/s12672-022-00490-5.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: Protocollo xx/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data available on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No