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OpenTrials
Completed

NCT Number: NCT05259488

Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy

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.

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Key information

Conditions

Gastric Cancer Digestive Cancer Digestive System Diseases Digestive System Neoplasms Gastric Neoplasm Gastrointestinal Diseases Gastrointestinal Neoplasms Laparoscopic Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunonutrition

Dietary Supplement

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

Primary outcomes

  1. 30-days postoperative complications

    Time frame: up to 30 days after discharge

    Rate of any complication after colorectal resection

  2. LOS

    Time frame: up to 30 days after discharge

    number of days between primary colorectal resection and discharge

Secondary outcomes

  1. Anastomotic leak

    Time frame: up to 30 days after discharge

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

  2. Pneumonia

    Time frame: up to 30 days after discharge

    rate of radiologically demonstrated pneumonia

  3. Ileus

    Time frame: up to 30 days after discharge

    rate of any ileus clinically demonstrated

  4. Prolonged length of stay

    Time frame: up to 30 days after discharge

    rate of any patient discharged after 15 days

  5. Readmission

    Time frame: up to 30 days after discharge

    Rate of any unplanned readmission after discharge

  6. Mortality

    Time frame: up to 30 days after discharge

    Rate of any mortality

  7. Time of first defacation

    Time frame: up to 30 days after discharge

    time to first bowel opened to stool

  8. Time of tolerated fluid intake

    Time frame: up to 30 days after discharge

    time to first tolerated fluid intake

  9. Time of tolerated food intake

    Time frame: up to 30 days after discharge

    time to first tolerated food intake

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2022
First posted
Feb 28, 2022
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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