Symbiotics to Prevent Postoperative Infection in Colorectal Cancer

October 7, 2015 updated by: Aline Gamarra Taborda, Hospital de Clinicas de Porto Alegre

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 91770-545
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Aline Taborda, ms, Federal University of Health Science of Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • symbioticcolorectalcancer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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