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Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy

NCT ID: NCT05259488

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2022-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Surgery Laparoscopic Gastric Neoplasm Digestive Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients receiving immunonutrition supply

Dietary Supplement: Immunonutrition nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery

immunonutrition

Intervention Type DIETARY_SUPPLEMENT

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

historical control group

standard dietary advice

No interventions assigned to this group

Interventions

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immunonutrition

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Sigismondo Sica

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 35816241 (View on PubMed)

Other Identifiers

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Protocollo xx/22

Identifier Type: -

Identifier Source: org_study_id