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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05259488
Other study ID # Protocollo xx/22
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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