Preoperative Immunonutrition in Patients Undergoing Elective Colorectal Surgery for Neoplasm

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-10-31

Brief Summary

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Enhanced Recovery After Surgery (ERAS) protocols were developed to standardize perioperative practice in colon surgery to reduce morbidity, improve recovery, and shorten length of stay (LOS). Better protocol adherence translates into fewer readmissions and complications, and better 5-year survival. Preoperative elements, especially nutrition and immunonutrition, are topics that need further development to become the standard of care. It has been widely reported that the prevalence of malnutrition reaches 40% in cancer patients at the time of diagnosis. Impaired nutritional status at the time of surgery and cancer-induced inflammation, along with postoperative inflammatory responses to major surgery, increase the risk of postoperative complications, along with a decrease in perceived quality of life.

Immunonutrition can modulate inflammation and reduce postoperative infections and shorten length of stay by counteracting the immune response induced by cancer. Adipose tissue has been shown to be a relevant source of inflammatory mediators, which may play a role in the promotion of tumor cachexia.

The present study is a multicenter randomized control study (RCT) designed to evaluate the effect of preoperative immunonutrition in patients with colorectal cancer eligible for elective minimally invasive procedures, evaluating in particular surgical site infection and length of hospital stay. A biopsy of subcutaneous adipose tissue and visceral adipose tissue will also be performed, in order to evaluate the differences between inflammatory infiltrate, degree of fibrosis and cross-sectional area of adipocytes compared to controls.

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Detailed Description

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Conditions

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Cancer of Colon Nutrition Related Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A, Impact oral + Colorectal Surgery

the supplement Oral Impact will be administered 3 times a day for 10 days before the operation.

Colon surgery will be performed according to standard clinical practice.

Group Type ACTIVE_COMPARATOR

Oral Impact Nestle

Intervention Type DIETARY_SUPPLEMENT

Oral Impact Nestle will be administered per os 3 times per day for 10 days before colorectal surgery

Colorectal surgery

Intervention Type PROCEDURE

Colorectal surgery will include right colectomy, left colectomy, transverse colectomy, anterior rectal resection. All procedures will be performed according to the standard clinical practice.

B, Placebo group + Colorectal Surgery

A Placebo will be administered 3 times a day for 10 days before the operation. Colon surgery will be performed according to standard clinical practice.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

A Placebo will be administered per os 3 times per day for 10 days before colorectal surgery

Colorectal surgery

Intervention Type PROCEDURE

Colorectal surgery will include right colectomy, left colectomy, transverse colectomy, anterior rectal resection. All procedures will be performed according to the standard clinical practice.

Interventions

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Placebo

A Placebo will be administered per os 3 times per day for 10 days before colorectal surgery

Intervention Type OTHER

Oral Impact Nestle

Oral Impact Nestle will be administered per os 3 times per day for 10 days before colorectal surgery

Intervention Type DIETARY_SUPPLEMENT

Colorectal surgery

Colorectal surgery will include right colectomy, left colectomy, transverse colectomy, anterior rectal resection. All procedures will be performed according to the standard clinical practice.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* primary colorectal neoplasms eligible for elective surgery, undergoing minivasive resections.
* 20 to 85 years old, with no difficulties in oral intake
* BMI ranging from 18 to 40.

Exclusion Criteria

* emergency surgery,
* converted procedures,
* major intraoperative complications,
* concomitant chronic disease such as chronic renal failure, rheumatic and hematological disease, chronic inflammatory bowel diseases,
* synchronous cancer,
* previous bowel resections or bariatric surgery,
* presence of preoperative stoma.

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No