Surgery Clinical Trial
Official title:
Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy: a Single-centre Comparative Study
Verified date | February 2022 |
Source | University of Rome Tor Vergata |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Rome Tor Vergata |
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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