Symbiotics to Prevent Postoperative Infection in Colorectal Cancer

Not Applicable

• Conditions: Colorectal Cancer; Surgical Site Infection
• Interventions: Dietary Supplement: symbiotic group; Dietary Supplement: placebo group

• Registration Number: NCT02571374
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-04-11
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-07
• Last Update Submitted: 2015-10-07
• Study First Posted: 2015-10-08
• Last Update Posted: 2015-10-08
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
symbiotic group	symbiotic group	Symbiotic group
placebo group	placebo group	placebo group

Primary Outcome Measures

Name	Time	Method
Number of participants with colorectal cancer on symbiotic to prevent postoperative infection	1 month	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.

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil