Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy
1 other identifier
observational
51
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2014
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 17, 2022
CompletedFirst Posted
Study publicly available on registry
February 28, 2022
CompletedFebruary 28, 2022
February 1, 2022
8 years
February 17, 2022
February 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
30-days postoperative complications
Rate of any complication after colorectal resection
up to 30 days after discharge
LOS
number of days between primary colorectal resection and discharge
up to 30 days after discharge
Secondary Outcomes (9)
Anastomotic leak
up to 30 days after discharge
Pneumonia
up to 30 days after discharge
Ileus
up to 30 days after discharge
Prolonged length of stay
up to 30 days after discharge
Readmission
up to 30 days after discharge
- +4 more secondary outcomes
Study Arms (2)
patients receiving immunonutrition supply
Dietary Supplement: Immunonutrition nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery
historical control group
standard dietary advice
Interventions
nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery
Eligibility Criteria
All normonourished patients undergoing elective ERAS laparoscopic total gastrectomy for cancer at Minimally Invasive Surgery Unit of Tor Vergata University Hospital
You may qualify if:
- Age \>18 years
- Primary gastric cancer
- Preoperative staging I-III
- Eligible for laparoscopic D2 total gastrectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Franceschilli M, Siragusa L, Usai V, Dhimolea S, Pirozzi B, Sibio S, Di Carlo S. Immunonutrition reduces complications rate and length of stay after laparoscopic total gastrectomy: a single unit retrospective study. Discov Oncol. 2022 Jul 11;13(1):62. doi: 10.1007/s12672-022-00490-5.
PMID: 35816241DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
February 17, 2022
First Posted
February 28, 2022
Study Start
January 1, 2014
Primary Completion
December 31, 2021
Study Completion
January 1, 2022
Last Updated
February 28, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share
data available on request