Symbiotics to Prevent Postoperative Infection in Colorectal Cancer

Study Overview
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Brief Summary
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This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. The researchers will compare incidence of surgical site infection between the study groups.

Detailed Description
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This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be randomly selected to receive either a symbiotic formulation or placebo during the perioperative period. The researchers will compare incidence of surgical site infection, detected by clinical examination and complementary tests (CT scans, X-rays, microbiological and hematological tests) between the study groups.

Official Title
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Change in Incidence of Surgical Site Infection After Resection of Colorectal Cancer Between Patients Receiving a Symbiotic Compound and Patients Receiving a Placebo.

Conditions
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Colorectal Cancer, Surgical Site Infection

Intervention / Treatment
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* Dietary Supplement: symbiotic group
* Dietary Supplement: placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between 18 and 85 years old; Colorectal cancer patients. Ability to understand and signing the informed consent Exclusion Criteria: Pregnancy (early diagnosis) Reduced intellectual level that could prevent proper understanding of the objectives of the study Patients with rectal cancer undergoing neoadjuvant treatment (chemotherapy and radiotherapy) Use of products with prebiotic, probiotic and / or symbiotic function or fiber module; by more than 3x a week Refusal to participate and / or to sign the Consent Form Free and Clear

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: symbiotic group<br>Symbiotic group | Dietary Supplement: symbiotic group<br>* this group received sachets of symbiotic<br>|
| Placebo Comparator: placebo group<br>placebo group | Dietary Supplement: placebo group<br>* this group received placebo<br>* Other names: maltodextrina;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with colorectal cancer on symbiotic to prevent postoperative infection | This is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. After we will compare the number of participants with incidence of surgical site infection between the study groups. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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symbiotic, colorectal cancer