Symbiotics to Prevent Postoperative Infection in Colorectal Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Surgical Site Infection
• Intervention / Treatment: Dietary supplement: symbiotic group; Dietary supplement: placebo group

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 Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aline Taborda, ms; Phone Number: 555130849948; Email: alinegamarrat@hotmail.com
• Study Contact Backup: Name: Daniel Damin, dr; Phone Number: 55 51 3359-8000; Email: damin@terra.com.br

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 91770-545
      • Recruiting
      • Hospital de Clinicas de Porto Alegre
      • Contact: aline taborda, ms; Phone Number: 5191065005; Email: alinegamarrat@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: symbiotic group; Symbiotic group	Dietary supplement: symbiotic group; this group received sachets of symbiotic
PLACEBO_COMPARATOR: placebo group	Dietary supplement: placebo group; this group received placebo; Other Names: maltodextrina

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Aline Taborda, ms, Federal University of Health Science of Porto Alegre

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2015
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: April 11, 2014
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (ESTIMATE): October 8, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): October 8, 2015
• Last Update Submitted That Met QC Criteria: October 7, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: colorectal cancer; symbiotic
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Wound Infection; Infections; Communicable Diseases; Colorectal Neoplasms; Surgical Wound Infection
• Other Study ID Numbers: symbioticcolorectalcancer