Symbiotics to Prevent Postoperative Infection in Colorectal Cancer

Colorectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02571374
• Other study ID #: symbioticcolorectalcancer
• Status: Recruiting
• Phase: N/A
• First received: April 11, 2014
• Last updated: October 7, 2015
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Aline Taborda, ms
• Phone: 555130849948
• Email: alinegamarrat[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Dietary Supplement:
• symbiotic group
this group received sachets of symbiotic
• placebo group
this group received placebo

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No