Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05259488
• Other study ID #: Protocollo xx/22
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: January 1, 2022

Study information

• Verified date: February 2022
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 1, 2022
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive Cancer
• Gastric Cancer
• Gastric Neoplasm
• Laparoscopic
• Stomach Neoplasms
• Surgery

Intervention

Dietary Supplement:
• immunonutrition
nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-days postoperative complications	Rate of any complication after colorectal resection	up to 30 days after discharge
Primary	LOS	number of days between primary colorectal resection and discharge	up to 30 days after discharge
Secondary	Anastomotic leak	rate of any postoperative leakage of oesophagojejunal, jejunojejunal anastomosis, clinically, radiologically or endoscopically demonstrated	up to 30 days after discharge
Secondary	Pneumonia	rate of radiologically demonstrated pneumonia	up to 30 days after discharge
Secondary	Ileus	rate of any ileus clinically demonstrated	up to 30 days after discharge
Secondary	Prolonged length of stay	rate of any patient discharged after 15 days	up to 30 days after discharge
Secondary	Readmission	Rate of any unplanned readmission after discharge	up to 30 days after discharge
Secondary	Mortality	Rate of any mortality	up to 30 days after discharge
Secondary	Time of first defacation	time to first bowel opened to stool	up to 30 days after discharge
Secondary	Time of tolerated fluid intake	time to first tolerated fluid intake	up to 30 days after discharge
Secondary	Time of tolerated food intake	time to first tolerated food intake	up to 30 days after discharge