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Symbiotics to Prevent Postoperative Infection in Colorectal Cancer

Primary Purpose

Colorectal Cancer, Surgical Site Infection

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
symbiotic group
placebo group
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring symbiotic, colorectal cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital de Clinicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

symbiotic group

placebo group

Arm Description

Symbiotic group

placebo group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2014
Last Updated
October 7, 2015
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02571374
Brief Title
Symbiotics to Prevent Postoperative Infection in Colorectal Cancer
Official Title
Change in Incidence of Surgical Site Infection After Resection of Colorectal Cancer Between Patients Receiving a Symbiotic Compound and Patients Receiving a Placebo.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Surgical Site Infection
Keywords
symbiotic, colorectal cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
symbiotic group
Arm Type
Experimental
Arm Description
Symbiotic group
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
placebo group
Intervention Type
Dietary Supplement
Intervention Name(s)
symbiotic group
Intervention Description
this group received sachets of symbiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo group
Other Intervention Name(s)
maltodextrina
Intervention Description
this group received placebo
Primary Outcome Measure Information:
Title
Number of participants with colorectal cancer on symbiotic to prevent postoperative infection
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aline Taborda, ms
Phone
555130849948
Email
alinegamarrat@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Damin, dr
Phone
55 51 3359-8000
Email
damin@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aline Taborda, ms
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
91770-545
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
aline taborda, ms
Phone
5191065005
Email
alinegamarrat@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Symbiotics to Prevent Postoperative Infection in Colorectal Cancer

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