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.
1 other identifier
interventional
92
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Oct 2013
Typical duration for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 11, 2014
CompletedFirst Posted
Study publicly available on registry
October 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedOctober 8, 2015
October 1, 2015
2.2 years
April 11, 2014
October 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
symbiotic group
EXPERIMENTALSymbiotic group
placebo group
PLACEBO COMPARATORplacebo group
Interventions
Eligibility Criteria
You may qualify if:
- Adults between 18 and 85 years old;
- Colorectal cancer patients.
- Ability to understand and signing the informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 91770-545, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aline Taborda, ms
Federal University of Health Science of Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ms
Study Record Dates
First Submitted
April 11, 2014
First Posted
October 8, 2015
Study Start
October 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
October 8, 2015
Record last verified: 2015-10