Symbiotics to Prevent Postoperative Infection in Colorectal Cancer

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Surgical Site Infection; Colorectal Cancer

Treatments: Dietary Supplement: placebo group; Dietary Supplement: symbiotic group

Study type: Interventional

Funder types: Other

Identifiers

NCT02571374

symbioticcolorectalcancer

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 2 patient groups, including a placebo group

symbiotic group

Experimental group

Description:

Symbiotic group

Treatment:

Dietary Supplement: symbiotic group

placebo group

Placebo Comparator group

Description:

placebo group

Treatment:

Dietary Supplement: placebo group