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Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05259488
Enrollment
51
Registered
2022-02-28
Start date
2014-01-01
Completion date
2022-01-01
Last updated
2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive Cancer, Gastric Cancer, Gastric Neoplasm, Laparoscopic, Surgery

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.

Interventions

DIETARY_SUPPLEMENTimmunonutrition

nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery

Sponsors

University of Rome Tor Vergata
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
30-days postoperative complicationsup to 30 days after dischargeRate of any complication after colorectal resection
LOSup to 30 days after dischargenumber of days between primary colorectal resection and discharge

Secondary

MeasureTime frameDescription
Ileusup to 30 days after dischargerate of any ileus clinically demonstrated
Prolonged length of stayup to 30 days after dischargerate of any patient discharged after 15 days
Readmissionup to 30 days after dischargeRate of any unplanned readmission after discharge
Anastomotic leakup to 30 days after dischargerate of any postoperative leakage of oesophagojejunal, jejunojejunal anastomosis, clinically, radiologically or endoscopically demonstrated
Time of first defacationup to 30 days after dischargetime to first bowel opened to stool
Time of tolerated fluid intakeup to 30 days after dischargetime to first tolerated fluid intake
Time of tolerated food intakeup to 30 days after dischargetime to first tolerated food intake
Mortalityup to 30 days after dischargeRate of any mortality
Pneumoniaup to 30 days after dischargerate of radiologically demonstrated pneumonia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026