Preoperative Immunonutrition in Normonourished Patients Undergoing Fast-track Laparoscopic Colorectal Surgery

NCT ID: NCT04692545

Last Updated: 2021-01-05

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

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2020-06-01

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 colorectal cancer surgery. Potential benefits of combining preoperative IN (PIN) with protocols of enhanced recovery after surgery (ERAS) in reducing LOS in laparoscopic surgery are yet to be determined.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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A

patients receiving immunonutrition supply

Immunonutrition

Intervention Type DIETARY_SUPPLEMENT

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

B

patients receiving 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

* laparoscopic colorectal resection for cancer following ERAS protocol
* \>18 years old
* elective setting

Exclusion Criteria

* age below 18
* malnutrition
* inflammatory bowel disease
* acquired or congenital immunodeficiency
* preoperative infection
* ASA IV
* pregnancy
* emergency setting
* conversion to open surgery
* multivisceral resections
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

MD, PhD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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REGISTROSPERIMENTAZIONI /21

Identifier Type: -

Identifier Source: org_study_id

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